Trial Outcomes & Findings for Open Label Use Of RiaStap During Aortic Reconstruction (NCT NCT01300286)
NCT ID: NCT01300286
Last Updated: 2014-12-25
Results Overview
Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
Anesthesia Induction (Baseline), Pre RiaSTAP (est. 4 hr after baseline), Post RiaSTAP (est: 10 minutes after RiaSTAP administered), ICU Admission (est. 6 hours after baseline), 24 Hour post op (est: 24-30 hr after baseline)
Results posted on
2014-12-25
Participant Flow
Participant milestones
| Measure |
RiaSTAP
RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
RiaSTAP
RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
|
|---|---|
|
Overall Study
did not get dosed
|
1
|
Baseline Characteristics
Open Label Use Of RiaStap During Aortic Reconstruction
Baseline characteristics by cohort
| Measure |
RiaSTAP
n=23 Participants
RiaSTAP: One time dose of 70 mg/kg will be administered intravenously
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 13 • n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Anesthesia Induction (Baseline), Pre RiaSTAP (est. 4 hr after baseline), Post RiaSTAP (est: 10 minutes after RiaSTAP administered), ICU Admission (est. 6 hours after baseline), 24 Hour post op (est: 24-30 hr after baseline)Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.
Outcome measures
| Measure |
RiaSTAP
n=22 Participants
One time dose of 70 mg/kg will be administered intravenously.
|
|---|---|
|
Fibrinogen Level Change
Anesthesia Induction,I
|
317 mg/dl
Standard Deviation 49
|
|
Fibrinogen Level Change
Pre RiaSTAP
|
235 mg/dl
Standard Deviation 39
|
|
Fibrinogen Level Change
Post RiaSTAP
|
331 mg/dl
Standard Deviation 41
|
|
Fibrinogen Level Change
ICU admission
|
312 mg/dl
Standard Deviation 41
|
|
Fibrinogen Level Change
24 hours post op
|
372 mg/dl
Standard Deviation 45
|
SECONDARY outcome
Timeframe: Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)Outcome measures
| Measure |
RiaSTAP
n=22 Participants
One time dose of 70 mg/kg will be administered intravenously.
|
|---|---|
|
Packed Red Blood Cell Transfusion
|
1 units
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)Outcome measures
| Measure |
RiaSTAP
n=22 Participants
One time dose of 70 mg/kg will be administered intravenously.
|
|---|---|
|
Fresh Frozen Plasma Transfusion
|
1000 mL
Interval 1000.0 to 1500.0
|
SECONDARY outcome
Timeframe: Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)Outcome measures
| Measure |
RiaSTAP
n=22 Participants
One time dose of 70 mg/kg will be administered intravenously.
|
|---|---|
|
Platelet Transfusion
|
400 mL
Interval 274.0 to 592.0
|
SECONDARY outcome
Timeframe: Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)Outcome measures
| Measure |
RiaSTAP
n=22 Participants
One time dose of 70 mg/kg will be administered intravenously.
|
|---|---|
|
Cryoprecipitate Transfusion
|
20 mL
Standard Deviation 59
|
Adverse Events
RiaSTAP
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RiaSTAP
n=22 participants at risk
RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
|
|---|---|
|
Cardiac disorders
Postoperative atrial fibrillation
|
27.3%
6/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place