Trial Outcomes & Findings for Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury (NCT NCT01400893)
NCT ID: NCT01400893
Last Updated: 2021-04-27
Results Overview
All cause mortality through day 60 post-randomization. The outcome data reported here describe the mortality at Day 60 (primary endpoint) of the treated subjects which received the recommended ionized calcium (riCa) for ≥ 90% of treatment time.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
Day 60 following treatment initiation
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
CRRT + SCD
Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
|
CRRT Alone
Patients with a diagnosis of acute kidney injury and multiorgan failure requiring CRRT will be randomized
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
65
|
|
Overall Study
COMPLETED
|
42
|
38
|
|
Overall Study
NOT COMPLETED
|
27
|
27
|
Reasons for withdrawal
| Measure |
CRRT + SCD
Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
|
CRRT Alone
Patients with a diagnosis of acute kidney injury and multiorgan failure requiring CRRT will be randomized
|
|---|---|---|
|
Overall Study
Death
|
27
|
21
|
|
Overall Study
Lost to Follow-up
|
0
|
6
|
Baseline Characteristics
Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
Baseline characteristics by cohort
| Measure |
CRRT + SCD
n=69 Participants
Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
|
CRRT Alone
n=65 Participants
Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 13.1 • n=99 Participants
|
53.5 years
STANDARD_DEVIATION 14.7 • n=107 Participants
|
55.4 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=99 Participants
|
65 participants
n=107 Participants
|
134 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 60 following treatment initiationPopulation: Outcome data is reported for those subjects in which the calcium levels were maintained in the protocol's recommended range (≤0.4 mmol/L) for greater or equal to 90% of the therapy time.
All cause mortality through day 60 post-randomization. The outcome data reported here describe the mortality at Day 60 (primary endpoint) of the treated subjects which received the recommended ionized calcium (riCa) for ≥ 90% of treatment time.
Outcome measures
| Measure |
CRRT + SCD
n=19 Participants
Patients with a diagnosis of AKI requires CRRT will be randomized
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
|
CRRT Alone
n=27 Participants
Patients with a diagnosis of AKI requires CRRT will be randomized
|
|---|---|---|
|
The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.
Dead
|
3 Participants
|
11 Participants
|
|
The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.
Alive
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 60 following treatment initiationPopulation: per protocol.
RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy.
Outcome measures
| Measure |
CRRT + SCD
n=19 Participants
Patients with a diagnosis of AKI requires CRRT will be randomized
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
|
CRRT Alone
n=26 Participants
Patients with a diagnosis of AKI requires CRRT will be randomized
|
|---|---|---|
|
Renal Replacement Therapy Dependency at Day 60.
|
3 Participants
|
15 Participants
|
Adverse Events
CRRT + SCD
Serious events: 45 serious events
Other events: 0 other events
Deaths: 27 deaths
CRRT Alone
Serious events: 40 serious events
Other events: 0 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
CRRT + SCD
n=69 participants at risk
Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
|
CRRT Alone
n=63 participants at risk
Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
11.6%
8/69 • Number of events 8 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
4.8%
3/63 • Number of events 3 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Cardiac disorders
Cardiac disorders
|
17.4%
12/69 • Number of events 12 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
15.9%
10/63 • Number of events 10 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
5.8%
4/69 • Number of events 4 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
9.5%
6/63 • Number of events 6 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
General disorders
General disorders and administration site conditions
|
5.8%
4/69 • Number of events 4 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
11.1%
7/63 • Number of events 7 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Infections and infestations
Infections and infestations
|
17.4%
12/69 • Number of events 12 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
15.9%
10/63 • Number of events 10 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural conplications
|
1.4%
1/69 • Number of events 1 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
0.00%
0/63 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Investigations
Investigations
|
0.00%
0/69 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
1.6%
1/63 • Number of events 1 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
2.9%
2/69 • Number of events 2 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
3.2%
2/63 • Number of events 2 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
1.4%
1/69 • Number of events 1 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
1.6%
1/63 • Number of events 1 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/69 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
1.6%
1/63 • Number of events 1 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
1.4%
1/69 • Number of events 1 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
4.8%
3/63 • Number of events 3 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
14.5%
10/69 • Number of events 10 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
15.9%
10/63 • Number of events 10 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/69 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
3.2%
2/63 • Number of events 2 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
|
Vascular disorders
Vascular disorders
|
10.1%
7/69 • Number of events 7 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
6.3%
4/63 • Number of events 4 • Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol. Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU. Other Adverse Events were not collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place