Trial Outcomes & Findings for t-PA Prophylaxis to Prevent Catheter-associated Thrombosis and Infection (NCT NCT03672006)
NCT ID: NCT03672006
Last Updated: 2021-07-13
Results Overview
Catheter-associated Venous Thrombosis upon ICU discharge or 30 days
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
30 days or ICU discharge
Results posted on
2021-07-13
Participant Flow
Participant milestones
| Measure |
Alteplase
10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)
alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter
|
Heparin
9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)
Heparin: Medication administered to dwell in central venous catheter
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Alteplase
10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)
alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter
|
Heparin
9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)
Heparin: Medication administered to dwell in central venous catheter
|
|---|---|---|
|
Overall Study
exclusion criteria met
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Alteplase
n=10 Participants
10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)
alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter
|
Heparin
n=9 Participants
9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)
Heparin: Medication administered to dwell in central venous catheter
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.5 years
n=10 Participants
|
3 years
n=9 Participants
|
3 years
n=19 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
3 Participants
n=9 Participants
|
7 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
6 Participants
n=9 Participants
|
12 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
9 participants
n=9 Participants
|
19 participants
n=19 Participants
|
|
CVC type
Untunneled
|
7 Participants
n=10 Participants
|
8 Participants
n=9 Participants
|
15 Participants
n=19 Participants
|
|
CVC type
PICC
|
2 Participants
n=10 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=19 Participants
|
|
CVC type
Broviac/Hickman
|
1 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: 30 days or ICU dischargeCatheter-associated Venous Thrombosis upon ICU discharge or 30 days
Outcome measures
| Measure |
Alteplase
n=10 Participants
10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)
alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter
|
Heparin
n=9 Participants
9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)
Heparin: Medication administered to dwell in central venous catheter
|
|---|---|---|
|
Catheter-associated Venous Thrombosis
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 30 days or ICU dischargeCLABSI
Outcome measures
| Measure |
Alteplase
n=10 Participants
10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)
alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter
|
Heparin
n=9 Participants
9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)
Heparin: Medication administered to dwell in central venous catheter
|
|---|---|---|
|
Catheter-associated Bloodstream Infection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days or ICU dischargePopulation: episode of CVC dysfunction as inability to flush or draw
Episodes of CVC dysfunction
Outcome measures
| Measure |
Alteplase
n=10 Participants
10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)
alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter
|
Heparin
n=9 Participants
9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)
Heparin: Medication administered to dwell in central venous catheter
|
|---|---|---|
|
Episodes of CVC Dysfunction
|
5 episodes
|
2 episodes
|
SECONDARY outcome
Timeframe: 30 days or ICU dischargePopulation: number of episodes of off-study t-PA use
off study use
Outcome measures
| Measure |
Alteplase
n=10 Participants
10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)
alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter
|
Heparin
n=9 Participants
9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)
Heparin: Medication administered to dwell in central venous catheter
|
|---|---|---|
|
Off Study Use of t-PA
|
0.5 doses
Interval 0.0 to 1.0
|
0 doses
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 30 days or ICU dischargePopulation: Bleeding events defined as clinically significant
clinically significant bleeding
Outcome measures
| Measure |
Alteplase
n=10 Participants
10 patients received 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)
alteplase (recombinant t-PA): Medication administered to dwell in central venous catheter
|
Heparin
n=9 Participants
9 patients received 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)
Heparin: Medication administered to dwell in central venous catheter
|
|---|---|---|
|
Clinical Bleeding
|
0 episodes
|
0 episodes
|
Adverse Events
Alteplase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Heparin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place