Prevention of Postpartum Hemorrhage With Tranexamic Acid
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Postpartum Hemorrhage
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Three doses of Tranexamic acid (5 mg/kg, 10 mg/kg, and 15 mg/kg) will be used in a dose escalation fashion by cohort with the lowest dose first.Masking: Single (Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 49 years
- Gender
- Only males
Description
Conduct a prospective, open-label, dose finding PK study in 30 pregnant 3rd trimester women scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of the drug will be administered in an escalating fashion by cohort with the lowest dose first. A maximum of 1 gram will...
Conduct a prospective, open-label, dose finding PK study in 30 pregnant 3rd trimester women scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of the drug will be administered in an escalating fashion by cohort with the lowest dose first. A maximum of 1 gram will be administered. TXA serum levels at several time points after delivery will be assayed. A PK model will be constructed for determining the optimal TXA dose administered at parturition.
Tracking Information
- NCT #
- NCT03287336
- Collaborators
- National Institutes of Health (NIH)
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Principal Investigator: Homa Ahmadzia, MD George Washington University
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