Recruiting

Tranexamic Acid

Sponsor:

University of British Columbia

Code:

NCT06356948

Conditions

Healthy Participants

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Accepted

Interventions

Tranexamic Acid (TXA)

Study Details

Brief 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.

Conditions

Healthy Participants

Study ID

NCT06356948

Start date

Mar 30, 2024

Status verified date

Apr, 2024

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Accepted

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 Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Rapid-rate administration of TXA

This group will be administered tranexamic acid over 1 minute

active comparator: Slow-rate administration of TXA

This group will be administered tranexamic acid over 10 minutes

Interventions

Tranexamic Acid (TXA)

Study drug administration

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Aislynn Sharrock, BSc

604-875-2424aislynn.sharrock@cw.bc.ca

Locations

BC Women's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H3N1

Contacts

Aislynn Sharrock, BA (Hons.)

604-875-2158aislynn.sharrock@cw.bc.ca

Principal Investigator:

Anton Chau, MD MMSc

More Information

Sponsor

University of British Columbia

Last update posted

Apr 10, 2024

Last verified

Apr, 2024

Keywords

  • tranexamic acid
  • infusion rate
  • post-partum hemorrhage
  • hypotension
  • cesarean delivery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-04-10.