NCT06356948

Rate of Tranexamic Acid Administration on Blood Pressure (RateTXA) Study.

The Effect of Tranexamic Acid Rate of Administration on Blood Pressure in Healthy Pregnant Women Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia - A Prospective, Randomized, Double-blind, Non-inferiority Trial.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

Tranexamic acid is a well-established treatment for post-partum hemorrhage. This study aims to examine the effect of tranexamic acid administration rates on blood pressure changes over 1 minute compared to 10 minutes in healthy pregnant patients scheduled for cesarean delivery.

Detailed description

Women who are clinically diagnosed with post-partum hemorrhage during a vaginal or cesarean delivery should be immediately administered tranexamic acid according to the World Health Organization's recommendation. Tranexamic acid is a drug that inhibits the breakdown of fibrin clots which reduces blood loss. However, due to the risk of hypotension, the product monograph for TXA advises against rapid intravenous (IV) administration. Other clinical studies have also reported an increased incidence of nausea, vomiting, and visual disturbances; nonetheless, the results of these trials suggest that these side effects may be related to properties of TXA rather than the rate of administration. Therefore, the investigators of this study aim to determine if the rate of tranexamic acid administration has an effect on blood pressure in healthy pregnant patients who are scheduled for cesarean delivery under spinal anesthesia.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Tranexamic Acid (TXA)	Study drug administration

Timeline

• Start date: 2024-03-30
• Primary completion: 2027-07-30
• Completion: 2027-12-30
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: Canada