Trial Outcomes & Findings for Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn (NCT NCT00243243)
NCT ID: NCT00243243
Last Updated: 2016-05-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
24 hours
Results posted on
2016-05-26
Participant Flow
Patients with greater than 20% TBSA burn scheduled for excision and grafting will be randomized in the operating room.
If the excision and grafting was not the first for the patient.
Participant milestones
| Measure |
Experimental
Recombinant Factor VIIa : intravenous infusion of Factor VIIa
|
Control- Placebo
Intravenous infusion of a placebo
|
|---|---|---|
|
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
Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn
Baseline characteristics by cohort
| Measure |
Experimental
n=10 Participants
Recombinant Factor VIIa : intravenous infusion of Factor VIIa
|
Control
n=10 Participants
|
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
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 8.33 • n=99 Participants
|
28.8 years
STANDARD_DEVIATION 10.24 • n=107 Participants
|
29.1 years
STANDARD_DEVIATION 9.32 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Experimental
n=10 Participants
Recombinant Factor VIIa : intravenous infusion of Factor VIIa
|
Control- Placebo
n=10 Participants
Intravenous infusion of a placebo
|
|---|---|---|
|
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
Units of PRBC
|
68.9 units of blood components
|
87.2 units of blood components
|
|
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
Units of cryoprecipitate
|
0 units of blood components
|
4.1 units of blood components
|
|
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
Units of platelets
|
1.02 units of blood components
|
6.45 units of blood components
|
|
Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
Units of fresh frozen plasma
|
13.02 units of blood components
|
33.44 units of blood components
|
Adverse Events
Experimental
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
Control
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental
n=10 participants at risk
Recombinant Factor VIIa : intravenous infusion of Factor VIIa
|
Control
n=10 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
20.0%
2/10 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Immune system disorders
Sepsis
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
40.0%
4/10 • Number of events 7
|
30.0%
3/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle Necrosis
|
10.0%
1/10 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
|
Immune system disorders
Bacteremia
|
10.0%
1/10 • Number of events 3
|
0.00%
0/10
|
|
Renal and urinary disorders
Acute Kidney Injury
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
MI
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Vascular Disorders
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
Other adverse events
| Measure |
Experimental
n=10 participants at risk
Recombinant Factor VIIa : intravenous infusion of Factor VIIa
|
Control
n=10 participants at risk
|
|---|---|---|
|
Immune system disorders
Infection
|
70.0%
7/10 • Number of events 17
|
50.0%
5/10 • Number of events 9
|
|
Cardiac disorders
Rule Out Myocardial Infarction
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
20.0%
2/10 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Decreased Oxygen Saturation
|
20.0%
2/10 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Renal Insufficiency
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Hypotension
|
20.0%
2/10 • Number of events 2
|
20.0%
2/10 • Number of events 3
|
|
Hepatobiliary disorders
Liver Injury
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Upper Extremity Edema
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
Additional Information
David G. Baer, PhD, Director Research
US Army Institute of Surgical Research
Phone: 210-539-4327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place