Trial Outcomes & Findings for Tranexamic Acid and Thromboelastography During Cesarean Delivery (NCT NCT02026297)
NCT ID: NCT02026297
Last Updated: 2020-10-27
Results Overview
Blood samples will be collected for evaluation one our after initiation of the study infusion. Whole blood samples are tested in a point-of-care thromboelastography machine and R time, or time to initiation of clot formation, is measured in minutes.
TERMINATED
PHASE2
60 participants
one hour after initiation of study infusion
2020-10-27
Participant Flow
Participant milestones
| Measure |
Control, Low Risk PPH
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.
Placebo; Normal Saline: 0.9% Normal Saline
|
Treated, Low Risk PPH
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.
Tranexamic Acid: 1 gram IV over 10 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
13
|
|
Overall Study
COMPLETED
|
7
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tranexamic Acid and Thromboelastography During Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Control, Low Risk PPH
n=7 Participants
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.
Placebo; Normal Saline: 0.9% Normal Saline
|
Treated, Low Risk PPH
n=13 Participants
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.
Tranexamic Acid: 1 gram IV over 10 minutes
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.2 years
n=5 Participants
|
31.9 years
n=7 Participants
|
32.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one hour after initiation of study infusionPopulation: Thromboelastography R-time
Blood samples will be collected for evaluation one our after initiation of the study infusion. Whole blood samples are tested in a point-of-care thromboelastography machine and R time, or time to initiation of clot formation, is measured in minutes.
Outcome measures
| Measure |
Control, Low Risk PPH
n=7 Participants
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.
Placebo; Normal Saline: 0.9% Normal Saline
|
Treated, Low Risk PPH
n=13 Participants
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.
Tranexamic Acid: 1 gram IV over 10 minutes
|
|---|---|---|
|
TEG Value- Thromboelastography R-time, Control and Treated Groups
|
5.3 minutes
Interval 4.2 to 7.7
|
4.2 minutes
Interval 3.4 to 6.0
|
PRIMARY outcome
Timeframe: during surgery in the operating roomPopulation: weight of surgical sponges
Blood loss will be measured using the following methods: * visual estimate of blood in the suction canister * weight of surgical sponges * postoperative hemoglobin values
Outcome measures
| Measure |
Control, Low Risk PPH
n=7 Participants
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.
Placebo; Normal Saline: 0.9% Normal Saline
|
Treated, Low Risk PPH
n=13 Participants
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.
Tranexamic Acid: 1 gram IV over 10 minutes
|
|---|---|---|
|
Intraoperative Blood Loss
|
637 milliliters
Standard Error 151
|
685 milliliters
Standard Error 155
|
PRIMARY outcome
Timeframe: 6 weeks postpartumPopulation: postpartum Obstetrician evaluation at 6 weeks: obstetric bleeding requiring surgical intervention, blood transfusion, or both; thrombotic complications including: venous thrombus seen on ultrasound, thromboembolic event
The electronic patient record from each patients' 6-week postpartum visit will be reviewed for the following: * delayed bleeding complications, defined as obstetric bleeding requiring surgical intervention, blood transfusion, or both. * thrombotic complications including: venous thrombus seen on ultrasound, thromboembolic event
Outcome measures
| Measure |
Control, Low Risk PPH
n=7 Participants
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.
Placebo; Normal Saline: 0.9% Normal Saline
|
Treated, Low Risk PPH
n=13 Participants
Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.
Tranexamic Acid: 1 gram IV over 10 minutes
|
|---|---|---|
|
Delayed Complications at the 6-Week Postpartum Visit With the Obstetrician.
|
0 complications
|
0 complications
|
Adverse Events
Control, Low Risk PPH
Treated, Low Risk PPH
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