RecruitingPhase 4NCT06356948

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.


Sponsor

University of British Columbia

Enrollment

110 participants

Start Date

Mar 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 19 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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.

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Interventions

DRUGTranexamic Acid (TXA)

Study drug administration


Locations(1)

BC Women's Hospital

Vancouver, British Columbia, Canada

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NCT06356948


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