Trial Outcomes & Findings for Prevention of Postpartum Hemorrhage With Tranexamic Acid (NCT NCT03287336)
NCT ID: NCT03287336
Last Updated: 2025-03-25
Results Overview
Data obtained from assays of TXA in blood, dose group and patient characteristics; parameter estimates in 2 compartment model includes the clearance of the drug (L/hr).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Different time points ranging from surgery (T0) to 1 day postpartum.
Results posted on
2025-03-25
Participant Flow
Participant milestones
| Measure |
Cohort 1
Dose of Tranexamic acid 5mg/kg will be administered.
Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
|
Cohort 2
Dose of Tranexamic acid 10 mg/kg will be administered.
Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
|
Cohort 3
Dose of Tranexamic acid 15 mg/kg will be administered.
Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
15
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Baseline characteristics by cohort
| Measure |
Cohort 1
n=10 Participants
Dose of Tranexamic acid 5mg/kg will be administered.
Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
|
Cohort 2
n=10 Participants
Dose of Tranexamic acid 10 mg/kg will be administered.
Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
|
Cohort 3
n=10 Participants
Dose of Tranexamic acid 15 mg/kg will be administered.
Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
|
Total
n=30 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
34 years
n=5 Participants
|
31 years
n=7 Participants
|
33 years
n=5 Participants
|
33 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
30 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Different time points ranging from surgery (T0) to 1 day postpartum.Population: Groups are combined because in PKPD modeling the best model parameter estimates are determined from combination of individual participant data of the dose administered, patient characteristics, times of administration and drug level in plasma.
Data obtained from assays of TXA in blood, dose group and patient characteristics; parameter estimates in 2 compartment model includes the clearance of the drug (L/hr).
Outcome measures
| Measure |
5mg/kg
n=10 Participants
Dose group 1
|
10 mg/kg
n=10 Participants
Dose group 2
|
15 mg/kg
n=10 Participants
Dose group 3
|
|---|---|---|---|
|
PK Model Parameter Estimates
|
8.85 L/hr
Standard Deviation 2.24
|
10.39 L/hr
Standard Deviation 2.62
|
9.45 L/hr
Standard Deviation 2.37
|
PRIMARY outcome
Timeframe: Different time points ranging from surgery (T0) to 1 day postpartum.Population: Groups are combined because in PKPD modeling the best model parameter estimates are determined from combination of individual participant data of the dose administered, patient characteristics, times of administration and measured ML levels in plasma.
PD model parameters included concentration of TXA causing 50% of maximal fractional inhibition (IC50).
Outcome measures
| Measure |
5mg/kg
n=10 Participants
Dose group 1
|
10 mg/kg
n=10 Participants
Dose group 2
|
15 mg/kg
n=10 Participants
Dose group 3
|
|---|---|---|---|
|
Pharmacodynamics of Tranexamic Acid
|
5.49 mg/L
Standard Deviation 2.35
|
6.49 mg/L
Standard Deviation 2.88
|
9.45 mg/L
Standard Deviation 3.55
|
SECONDARY outcome
Timeframe: During surgeryIntraoperative blood loss
Outcome measures
| Measure |
5mg/kg
n=10 Participants
Dose group 1
|
10 mg/kg
n=10 Participants
Dose group 2
|
15 mg/kg
n=10 Participants
Dose group 3
|
|---|---|---|---|
|
Estimated Blood Loss
|
750 mL
Interval 600.0 to 2000.0
|
750 mL
Interval 518.0 to 1000.0
|
700 mL
Interval 400.0 to 800.0
|
SECONDARY outcome
Timeframe: During surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartumSafety parameters such as adverse events (including nausea/vomiting) and serious adverse events
Outcome measures
| Measure |
5mg/kg
n=10 Participants
Dose group 1
|
10 mg/kg
n=10 Participants
Dose group 2
|
15 mg/kg
n=10 Participants
Dose group 3
|
|---|---|---|---|
|
Safety Parameters
|
9 events
|
8 events
|
6 events
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3
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 |
Cohort 1
n=10 participants at risk
Dose of Tranexamic acid 5mg/kg will be administered.
Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
|
Cohort 2
n=10 participants at risk
Dose of Tranexamic acid 10 mg/kg will be administered.
Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
|
Cohort 3
n=10 participants at risk
Dose of Tranexamic acid 15 mg/kg will be administered.
Tranexamic Acid: Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
neonatal thrombosis
|
0.00%
0/10 • 6 weeks
|
0.00%
0/10 • 6 weeks
|
10.0%
1/10 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
facial rash
|
10.0%
1/10 • 6 weeks
|
0.00%
0/10 • 6 weeks
|
0.00%
0/10 • 6 weeks
|
|
Gastrointestinal disorders
nausea and vomiting
|
80.0%
8/10 • 6 weeks
|
60.0%
6/10 • 6 weeks
|
40.0%
4/10 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
itching
|
0.00%
0/10 • 6 weeks
|
10.0%
1/10 • 6 weeks
|
0.00%
0/10 • 6 weeks
|
|
Cardiac disorders
bradycardia
|
0.00%
0/10 • 6 weeks
|
10.0%
1/10 • 6 weeks
|
0.00%
0/10 • 6 weeks
|
|
Gastrointestinal disorders
blood in neonate's stool
|
0.00%
0/10 • 6 weeks
|
0.00%
0/10 • 6 weeks
|
10.0%
1/10 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place