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

NCT06356948 | Recruiting Phase 4 DMC

• 1 other identifier: H23-02918
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

tranexamic acid; infusion rate; post-partum hemorrhage; hypotension; cesarean delivery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of nausea

  Up to 4 hours from time of TXA administration until time of discharge from the recovery room

• Incidence of vomiting

  Up to 4 hours from time of TXA administration until time of discharge from the recovery room

• Incidence of hypotension

  Up to 4 hours from time of TXA administration until time of discharge from the recovery room

• Incidence of hypertension

  Up to 4 hours from time of TXA administration until time of discharge from the recovery room

• Incidence of central nervous system side effects

  Up to 4 hours from time of TXA administration until time of discharge from the recovery room

Study Arms (2)

Rapid-rate administration of TXA

ACTIVE COMPARATOR

This group will be administered tranexamic acid over 1 minute

Drug: Tranexamic Acid (TXA)

Slow-rate administration of TXA

ACTIVE COMPARATOR

This group will be administered tranexamic acid over 10 minutes

Drug: Tranexamic Acid (TXA)

Interventions

Tranexamic Acid (TXA) DRUG

Study drug administration

Also known as: Tranexamic Acid

Rapid-rate administration of TXA; Slow-rate administration of TXA

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H3N1, Canada

RECRUITING

Related Publications (13)

• 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.

  PMID: 30134136 BACKGROUND

• 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.

  PMID: 29090733 BACKGROUND

• 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.

  PMID: 35352277 BACKGROUND

• 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.

  PMID: 37311484 BACKGROUND

• 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.

  PMID: 23574458 BACKGROUND

• Novikova 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.

  PMID: 26079202 BACKGROUND

• 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.

  PMID: 37043652 BACKGROUND

• 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.

  PMID: 33913639 BACKGROUND

• 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.

  PMID: 29100880 BACKGROUND

• 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.

  PMID: 28456509 BACKGROUND

• 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.

  PMID: 20554319 BACKGROUND

• 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.

  PMID: 25797505 BACKGROUND

• 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.

  PMID: 22397329 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage; Hypotension

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Anton Chau, MD MMSc

  Department of Anesthesia BC Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aislynn Sharrock, BSc

CONTACT

604-875-2424; aislynn.sharrock@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: An anesthesiologist or anesthesia assistant not involved in the study will draw up TXA and labelling them based on the randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 10, 2024
• Study Start: March 30, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)