Healthy ParticipantsPhase 4RateTXANCT06356948
Rate of Tranexamic Acid Administration on Blood Pressure (RateTXA) Study.
A Phase 4 study testing Tranexamic Acid (TXA) in people with Healthy Participants, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Tranexamic Acid (TXA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2024to 30 Apr 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Tranexamic Acid (TXA)
- Keywords
- tranexamic acid, infusion rate, post-partum hemorrhage, hypotension, cesarean delivery
- Medical subject headings
- Postpartum Hemorrhage, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA)Drug
Also called Tranexamic Acid
Study drug administration
| Study group | Role | What they receive |
|---|---|---|
| Rapid-rate administration of TXA | Active comparator | This group will be administered tranexamic acid over 1 minute Receives: Drug: Tranexamic Acid (TXA) |
| Slow-rate administration of TXA | Active comparator | This group will be administered tranexamic acid over 10 minutes Receives: Drug: Tranexamic Acid (TXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between groups.
Change in systolic blood pressure from baseline over 15 minutes post-TXA administration between study and control groups
Measured: 15 minutes starting from the time of completed TXA administration.
Secondary outcomes (5)
Incidence of nausea
sensation of self-reported nausea documented every 5 minutes.
Measured: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of vomiting
vomiting documented every 5 minutes.
Measured: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of hypotension
Incidence of systolic blood pressure reduction greater than or equal to 20% of baseline
Measured: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of hypertension
Incidence of systolic blood pressure elevation greater than or equal to 20% of baseline
Measured: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Incidence of central nervous system side effects
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.
Measured: Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start30 Mar 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Chau, University of British Columbia
- Investigators
- Anton Chau, MD MMSc, Principal investigator, Department of Anesthesia BC Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356948
- Sponsor's protocol ID
- H23-02918
- Acronym
- RateTXA
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sentilhes L, Winer N, Azria E, Senat MV, Le Ray C, Vardon D, Perrotin F, Desbriere R, Fuchs F, Kayem G, Ducarme G, Doret-Dion M, Huissoud C, Bohec C, Deruelle P, Darsonval A, Chretien JM, Seco A, Daniel V, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery. N Engl J Med. 2018 Aug 23;379(8):731-742. doi: 10.1056/NEJMoa1800942.
PubMed 30134136Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
PubMed 29090733Boisselle ME, Zaphiratos VV, Fortier A, Richebe P, Loubert C. Comparison of carbetocin as a bolus or an infusion with prophylactic phenylephrine on maternal heart rate during Cesarean delivery under spinal anesthesia: a double-blinded randomized controlled trial. Can J Anaesth. 2022 Jun;69(6):715-725. doi: 10.1007/s12630-022-02227-y. Epub 2022 Mar 30.
PubMed 35352277Cheema HA, Ahmad AB, Ehsan M, Shahid A, Ayyan M, Azeem S, Hussain A, Shahid A, Nashwan AJ, Mikus M, Lagana AS. Tranexamic acid for the prevention of blood loss after cesarean section: an updated systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol MFM. 2023 Aug;5(8):101049. doi: 10.1016/j.ajogmf.2023.101049. Epub 2023 Jun 11.
PubMed 37311484Abdel-Aleem H, Alhusaini TK, Abdel-Aleem MA, Menoufy M, Gulmezoglu AM. Effectiveness of tranexamic acid on blood loss in patients undergoing elective cesarean section: randomized clinical trial. J Matern Fetal Neonatal Med. 2013 Nov;26(17):1705-9. doi: 10.3109/14767058.2013.794210. Epub 2013 May 10.
PubMed 23574458Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;2015(6):CD007872. doi: 10.1002/14651858.CD007872.pub3.
PubMed 26079202Pacheco LD, Clifton RG, Saade GR, Weiner SJ, Parry S, Thorp JM Jr, Longo M, Salazar A, Dalton W, Tita ATN, Gyamfi-Bannerman C, Chauhan SP, Metz TD, Rood K, Rouse DJ, Bailit JL, Grobman WA, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery. N Engl J Med. 2023 Apr 13;388(15):1365-1375. doi: 10.1056/NEJMoa2207419.
PubMed 37043652Sentilhes L, Senat MV, Le Lous M, Winer N, Rozenberg P, Kayem G, Verspyck E, Fuchs F, Azria E, Gallot D, Korb D, Desbriere R, Le Ray C, Chauleur C, de Marcillac F, Perrotin F, Parant O, Salomon LJ, Gauchotte E, Bretelle F, Sananes N, Bohec C, Mottet N, Legendre G, Letouzey V, Haddad B, Vardon D, Madar H, Mattuizzi A, Daniel V, Regueme S, Roussillon C, Benard A, Georget A, Darsonval A, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery. N Engl J Med. 2021 Apr 29;384(17):1623-1634. doi: 10.1056/NEJMoa2028788.
PubMed 33913639Vogel JP, Oladapo OT, Dowswell T, Gulmezoglu AM. Updated WHO recommendation on intravenous tranexamic acid for the treatment of post-partum haemorrhage. Lancet Glob Health. 2018 Jan;6(1):e18-e19. doi: 10.1016/S2214-109X(17)30428-X. Epub 2017 Oct 31. No abstract available.
PubMed 29100880WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
PubMed 28456509CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
PubMed 20554319Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23.
PubMed 25797505McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000.
PubMed 22397329