NCT03565276

Tranexamic Acid for Prevention of Postpartum Haemorrhage: a Dose-finding Study

Completed Phase 3 Last updated 23 September 2021

What this trial tests

Phase 3 trial testing Tranexamic Acid in Post Partum Hemorrhage in 24 participants. Completed in 19 August 2019.

Timeline

11 July 2018

Primary endpoint
14 March 2019

19 August 2019

Quick facts

Lead sponsor	Mount Sinai Hospital, Canada
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	24
Start date	11 July 2018
Primary completion	14 March 2019
Estimated completion	19 August 2019
Sites	1 location across Canada

Drugs / interventions tested

• Tranexamic Acid (Tranexamic Acid) — full drug profile →

Conditions studied

• Post Partum Hemorrhage — all drugs for Post Partum Hemorrhage →

Sponsor

Mount Sinai Hospital, Canada

Who can join

18 and older, female only, with Post Partum Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Published trials on tranexamic acid (TxA) for prevention have used a variety of fixed (0.5gm or 1gm) and body-weight adjusted (10mg/kg or 15mg/kg) doses of TxA. Given the wide range of bodyweights of pregnant women in contemporary obstetric practice, it is critical to determine the minimum effective dose of TxA, so as to avoid under- or over-dosing. The rationale of this study is to determine the minimum effective dose of TxA that is required to attain therapeutic plasma levels of TxA, established at 5-15mg/L, following administration of a single dose of intravenous (IV) TxA after childbirth and the clamping the umbilical cord, and before delivery of the placenta. Following birth of the infant, and upon clamping the umbilical cord, the investigators will administer a single dose of IV TxA in 100ml of 0.9% sodium chloride at 50mg/min according to the dose-escalation schedule described below. The slow rate of infusion has been chosen to prevent untoward effects such as hypotension that have been noted when the rate of infusion has exceeded 100mg/min. As part of the dose-escalation design, the investigators will start with 5mg/kg, half the smallest described dose, on a sample of up to 5 women. They will continue to administer TxA doses in increments of 5mg/kg to each successive batch of 5 women. If the number of treatment successes cannot statistically rule out a value \< 75% (\< 4 of 5 women are successes due to values in the low range), the dose will be increased by 5mg/kg for the next set of 5 women, and so on, until a maximum dose of 30mg/kg is reached, a dose deemed safe based on earlier studies in different populations. Once treatment success is determined at a certain dose, i.e. 4/5 women have levels in the therapeutic range), a total of 20 women will be administered that dose to ensure that 75% i.e. 18/20 women are successes at that dose.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.