Trial Outcomes & Findings for RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery (NCT NCT01283321)
NCT ID: NCT01283321
Last Updated: 2018-06-21
Results Overview
Bleeding scores are scored on a four-point scale. A visual assessment of surgical field was performed by the senior surgical staff as follows: 0 = excellent hemostasis (dry field), 1 = mild bleeding (oozing), 2 = moderate bleeding (controllable with applied pressure), and 3 = severe bleeding (multiple diffuse bleeding sites). If the visual bleeding scale was 2 to 3, the subjects were randomly assigned to a study intervention using a closed envelope method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
intra-operatively and up to 24 hours postoperatively
Results posted on
2018-06-21
Participant Flow
Enrollment started in February 2011 and the study was completed in May 2012. Subjects were recruited from Emory University. Fifty-one patients were approached after initial screening for eligibility, and 26 patients were consented.
Two subjects were excluded due to a change in surgical plans. Two subjects had low bleeding scores and were excluded.One subject had screening labs that were out of range for the study. One subject was treated using Dabigatran treatment. Total of six subjects that were excluded prior to randomization.
Participant milestones
| Measure |
Group A: RiaSTAP
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT \< 155 seconds, post CPB, with evidence of significant microvascular bleeding
|
Group B: Apheresis Platelets
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT \<155 seconds post CPB with evidence of significant microvascular bleeding.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery
Baseline characteristics by cohort
| Measure |
Group A: RiaSTAP
n=10 Participants
Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT \< 155 seconds, post CPB, with evidence of significant microvascular bleeding
|
Group B: Apheresis Platelets
n=10 Participants
single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT \<155 seconds post CPB with evidence of significant microvascular bleeding.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 5.3 • n=99 Participants
|
66.1 years
STANDARD_DEVIATION 8.9 • n=107 Participants
|
68.7 years
STANDARD_DEVIATION 7.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: intra-operatively and up to 24 hours postoperativelyBleeding scores are scored on a four-point scale. A visual assessment of surgical field was performed by the senior surgical staff as follows: 0 = excellent hemostasis (dry field), 1 = mild bleeding (oozing), 2 = moderate bleeding (controllable with applied pressure), and 3 = severe bleeding (multiple diffuse bleeding sites). If the visual bleeding scale was 2 to 3, the subjects were randomly assigned to a study intervention using a closed envelope method.
Outcome measures
| Measure |
Group A: RiaSTAP
n=10 Participants
Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT \< 155 seconds, post CPB, with evidence of significant microvascular bleeding
|
Group B: Apheresis Platelets
n=10 Participants
single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT \<155 seconds post CPB with evidence of significant microvascular bleeding.
|
|---|---|---|
|
Bleeding Scores
Postoperative
|
1.0 units on a scale
Standard Deviation 0.7
|
1.7 units on a scale
Standard Deviation 0.8
|
|
Bleeding Scores
Intraoperative
|
2.0 units on a scale
Standard Deviation 0.0
|
2.1 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Operative period up to 60 minutesOutcome measures
| Measure |
Group A: RiaSTAP
n=10 Participants
Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT \< 155 seconds, post CPB, with evidence of significant microvascular bleeding
|
Group B: Apheresis Platelets
n=10 Participants
single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT \<155 seconds post CPB with evidence of significant microvascular bleeding.
|
|---|---|---|
|
Number of Participants in Whom Transfusion of Platelet Concentrate is Required During or After Surgery.
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Operative period up to 60 minutes and up to 24 hours after surgeryOutcome measures
| Measure |
Group A: RiaSTAP
n=10 Participants
Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT \< 155 seconds, post CPB, with evidence of significant microvascular bleeding
|
Group B: Apheresis Platelets
n=10 Participants
single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT \<155 seconds post CPB with evidence of significant microvascular bleeding.
|
|---|---|---|
|
Volume (mL) of Fresh-frozen Plasma (FFP) Transfused-during Surgery and up to 24 Hours After Surgery
|
0 ml
Interval 0.0 to 1300.0
|
650 ml
Interval 0.0 to 1300.0
|
SECONDARY outcome
Timeframe: Operative period up to 60 minutes and up to 24 hours after surgeryOutcome measures
| Measure |
Group A: RiaSTAP
n=10 Participants
Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT \< 155 seconds, post CPB, with evidence of significant microvascular bleeding
|
Group B: Apheresis Platelets
n=10 Participants
single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT \<155 seconds post CPB with evidence of significant microvascular bleeding.
|
|---|---|---|
|
Volume (mL) of Platelets Transfused- During Surgery and up to 24 Hours After Surgery
|
0 ml
Interval 0.0 to 750.0
|
500 ml
Interval 250.0 to 1000.0
|
SECONDARY outcome
Timeframe: From end of surgery to 12 hours after surgeryOutcome measures
| Measure |
Group A: RiaSTAP
n=10 Participants
Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT \< 155 seconds, post CPB, with evidence of significant microvascular bleeding
|
Group B: Apheresis Platelets
n=10 Participants
single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT \<155 seconds post CPB with evidence of significant microvascular bleeding.
|
|---|---|---|
|
Median Blood Loss (mL) at 12 Hours After Surgery
|
925 ml
Interval 500.0 to 1693.0
|
1315 ml
Interval 653.0 to 2965.0
|
Adverse Events
Group A: RiaSTAP
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group B: Apheresis Platelets
Serious events: 6 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: RiaSTAP
n=10 participants at risk
Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT \< 155 seconds, post CPB, with evidence of significant microvascular bleeding
|
Group B: Apheresis Platelets
n=10 participants at risk
single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT \<155 seconds post CPB with evidence of significant microvascular bleeding.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/10 • Reported adverse events (AEs) include events starting during the surgery (intraoperative) and on and before 30 days after surgery (post-operative).
|
20.0%
2/10 • Reported adverse events (AEs) include events starting during the surgery (intraoperative) and on and before 30 days after surgery (post-operative).
|
|
Injury, poisoning and procedural complications
Excessive mediastinal bleeding
|
10.0%
1/10 • Reported adverse events (AEs) include events starting during the surgery (intraoperative) and on and before 30 days after surgery (post-operative).
|
30.0%
3/10 • Reported adverse events (AEs) include events starting during the surgery (intraoperative) and on and before 30 days after surgery (post-operative).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/10 • Reported adverse events (AEs) include events starting during the surgery (intraoperative) and on and before 30 days after surgery (post-operative).
|
10.0%
1/10 • Reported adverse events (AEs) include events starting during the surgery (intraoperative) and on and before 30 days after surgery (post-operative).
|
Other adverse events
| Measure |
Group A: RiaSTAP
n=10 participants at risk
Human fibrinogen concentrate
Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT \< 155 seconds, post CPB, with evidence of significant microvascular bleeding
|
Group B: Apheresis Platelets
n=10 participants at risk
single apheresis unit
apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT \<155 seconds post CPB with evidence of significant microvascular bleeding.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
30.0%
3/10 • Reported adverse events (AEs) include events starting during the surgery (intraoperative) and on and before 30 days after surgery (post-operative).
|
50.0%
5/10 • Reported adverse events (AEs) include events starting during the surgery (intraoperative) and on and before 30 days after surgery (post-operative).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place