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 range
19 Years
Sex
FEMALE
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.