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

Last updated: April 4, 2024
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Tranexamic Acid (TXA)

Clinical Study ID

NCT06356948
H23-02918
  • Ages > 19
  • Female
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 couldinclude beta those prescribed for anxiety (e.g. propranolol) or sedativepre-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 otherthan 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 thestudy team only speaks English and will be unable to complete consent process andstudy procedure appropriately.
  • Patients arriving late to the surgical day care with <90 min prior to scheduledcesarean delivery time resulting in potential delay for the operating room orinadequate time for consent and full execution of the protocol.

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Tranexamic Acid (TXA)
Phase: 4
Study Start date:
March 30, 2024
Estimated Completion Date:
December 30, 2027

Study 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.

Connect with a study center

  • BC Women's Hospital

    Vancouver, British Columbia V6H3N1
    Canada

    Active - Recruiting

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