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NCT Number: NCT06356948

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

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.

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Key information

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

BC Women's Hospital

Vancouver, British Columbia, V6H3N1, Canada

Location status: Recruiting

Location contact

Aislynn Sharrock, BA (Hons.)

CONTACT

[email protected]

604-875-2158 ext. 6335

Anton Chau, MD MMSc

PRINCIPAL_INVESTIGATOR

Juliana Barrera, MD MSc

SUB_INVESTIGATOR

Simon Wydall, MBBS MSc

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic acid (TXA)

Drug

Study drug administration

Other names: Tranexamic Acid

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aislynn Sharrock, BSc

CONTACT

[email protected]

604-875-2424 ext. 6335

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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.

Acronym: RateTXA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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