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

University of British Columbia

Status and phase: Enrolling; Phase 4

Conditions: Healthy Participants

Treatments: Drug: Tranexamic Acid (TXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06356948

H23-02918

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

110 participants in 2 patient groups

Rapid-rate administration of TXA

Active Comparator group

Description:

This group will be administered tranexamic acid over 1 minute

Treatment:

Drug: Tranexamic Acid (TXA)

Slow-rate administration of TXA

Active Comparator group

Description:

This group will be administered tranexamic acid over 10 minutes

Treatment:

Drug: Tranexamic Acid (TXA)