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

April 4, 2024 updated by: Anthony Chau, University of British Columbia

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H3N1
        • Recruiting
        • BC Women's Hospital
        • Contact:
        • Principal Investigator:
          • Anton Chau, MD MMSc
        • Sub-Investigator:
          • Simon Wydall, MBBS MSc
        • Sub-Investigator:
          • Juliana Barrera, MD MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant patients ≥34 weeks gestational age, for elective cesarean delivery under single-shot spinal anesthesia.
  • American Society of Anesthesiologists (ASA) Physical Status Class 2.
  • Patients ≥19 years of age.

Exclusion Criteria:

  • Known history of pre-existing hypertension or hypertension disorders of pregnancy.
  • Having recently taken a medication to treat high blood pressure (e.g. labetolol, hydralazine, nifedipine)
  • Having recently taken a medication that could alter blood pressure, which could include beta those prescribed for anxiety (e.g. propranolol) or sedative pre-medication (e.g. midazolam, lorazepam).
  • Known allergic reaction or hypersensitivity to TXA or any other TXA homologue.
  • Elective cesarean delivery requiring general anesthesia or a neuraxial technique other than a single-shot spinal (e.g. Epidural or Combined Spinal Epidural).
  • Patients who are unable to give informed consent due to a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.
  • Patients arriving late to the surgical day care with <90 min prior to scheduled cesarean delivery time resulting in potential delay for the operating room or inadequate time for consent and full execution of the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rapid-rate administration of TXA
This group will be administered tranexamic acid over 1 minute
Drug: Tranexamic Acid (TXA)
Study drug administration
Other Names:
  • Tranexamic Acid
Active Comparator: Slow-rate administration of TXA
This group will be administered tranexamic acid over 10 minutes
Drug: Tranexamic Acid (TXA)
Study drug administration
Other Names:
  • Tranexamic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups.
Time Frame: 15 minutes starting from the time of completed TXA administration.
Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between study and control groups
15 minutes starting from the time of completed TXA administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of nausea
Time Frame: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
sensation of self-reported nausea documented every 5 minutes.
Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of vomiting
Time Frame: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
vomiting documented every 5 minutes.
Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of hypotension
Time Frame: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of systolic blood pressure reduction greater than or equal to 20% of baseline
Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of hypertension
Time Frame: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of systolic blood pressure elevation greater than or equal to 20% of baseline
Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of central nervous system side effects
Time Frame: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
composite outcome of neurologic side effects including dizziness, headache, visual disturbances (photopsia) or facial flushing. These measures will be self-reported and documented every 5 minutes.
Up to 4 hours from time of TXA administration until time of discharge from the recovery room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Anton Chau, MD MMSc, Department of Anesthesia BC Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2024

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H23-02918

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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