Healthy Participants
Conditions
Keywords
tranexamic acid, infusion rate, post-partum hemorrhage, hypotension, cesarean delivery
Brief 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.
Detailed 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.
Interventions
DRUGTranexamic Acid (TXA)
Study drug administration
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
An anesthesiologist or anesthesia assistant not involved in the study will draw up TXA and labelling them based on the randomization.
Intervention model description
prospective, randomized, double-blind, non-inferiority trial. Arm 1: Intravenous infusion of TXA 1g (10 mL) administered over 1 minute. Arm 2: Intravenous infusion of TXA 1g (10 mL) administered over 10 minutes
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups. | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of nausea | 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. |
| Incidence of vomiting | Up to 4 hours from time of TXA administration until time of discharge from the recovery room | vomiting documented every 5 minutes. |
| Incidence of hypotension | 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 |
| Incidence of hypertension | 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 |
| Incidence of central nervous system side effects | 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. |
Countries
Canada
Contacts
Primary ContactAislynn Sharrock, BSc
Outcome results
None listed