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

Healthy Participants Clinical Trial

— RateTXA  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06356948
• Other study ID #: H23-02918
• Status: Recruiting
• Phase: Phase 4
• Start date: March 30, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: April 2024
• Source: University of British Columbia
• Contact: Aislynn Sharrock, BSc
• Phone: 604-875-2424
• Email: aislynn.sharrock[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 30, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Tranexamic Acid (TXA)
Study drug administration

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Abdel-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. — View Citation

Boisselle 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. — View Citation

Cheema 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. Erratum In: Am J Obstet Gynecol MFM. 2023 Dec;5(12):101196. — View Citation

CRASH-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. — View Citation

Kinsella 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. — View Citation

McCormack 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. — View Citation

Ng 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. — View Citation

Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;(6):CD007872. doi: 10.1002/14651858.CD007872.pub3. — View Citation

Pacheco 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. — View Citation

Sentilhes 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. — View Citation

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. — View Citation

Vogel 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. — View Citation

WOMAN 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. Erratum In: Lancet. 2017 May 27;389(10084):2104. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 minutes starting from the time of completed TXA administration.
Secondary	Incidence of nausea	sensation of self-reported nausea documented every 5 minutes.	Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Secondary	Incidence of vomiting	vomiting documented every 5 minutes.	Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Secondary	Incidence of hypotension	Incidence of systolic blood pressure reduction greater than or equal to 20% of baseline	Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Secondary	Incidence of hypertension	Incidence of systolic blood pressure elevation greater than or equal to 20% of baseline	Up to 4 hours from time of TXA administration until time of discharge from the recovery room
Secondary	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.	Up to 4 hours from time of TXA administration until time of discharge from the recovery room