Rate of Tranexamic Acid Administration on Blood Pressure (RateTXA) Study. (NCT06356948) | Clinical Trial Compass
RecruitingPhase 4
Rate of Tranexamic Acid Administration on Blood Pressure (RateTXA) Study.
Canada110 participantsStarted 2024-03-30
Plain-language 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.
Who can participate
Age range19 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups.
Timeframe: 15 minutes starting from the time of completed TXA administration.