Topical Tranexamic Acid in Caesarean Section

NCT02492087 | Unknown Phase 3 DMC

• 1 other identifier: NMRR-14-1034-20129
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate whether topical application of tranexamic acid into the uterine cavity and the surgical site intra-operatively can reduce blood loss and provide better surgical haemostasis in parturients with moderate to high risk for bleeding undergoing caesarean deliveries.

Conditions

Postpartum Haemorrhage

Keywords

topical; tranexamic acid; haemostasis; caesarean section; bleeding; postpartum hemorrhage; prophylactic

Outcome Measures

Primary Outcomes (1)

• Total intra-operative blood loss in the Tranexamic Acid (TXA) group compared to the Control group

  Total intra-operative blood loss will be measured at the end of the surgery (at wound closure). The following formula will be used: Total intra-operative blood loss (ml) = A + B - C where A = Blood volume in suction bottle (ml) B = Wet weight of all gauzes and drapes soaked with blood (g) C = Dry weight of all gauzes and drapes soaked with blood (g) (assumption of 1 gram of blood is equivalent to 1ml of blood) The blood loss quantified will be documented in subjects case report form

  From the start of the surgery (first surgical incision) up to the end of the surgery (at wound closure)

Secondary Outcomes (2)

• Transfusion requirements in terms of number of red blood cell packets transfused up to 24 hours post surgery

  From start of surgery (first surgical incision) up to 24 hours post surgery (wound closure)

• Haematocrit trends at baseline (Pre-operative) and at 6 hours post surgery in the TXA group and the Control group

  Pre-operatively within 24 hours prior to start of surgery (before surgical incision) up to 6 hours from the end of surgery (wound closure)

Study Arms (2)

Tranexamic acid (TXA) Group

ACTIVE COMPARATOR

Subjects in the TXA group will receive the topical tranexamic acid solution which will be administered intra-operatively, during the caesarean section on the surgical wound and into the intrauterine cavity after the delivery of the baby and the placenta. 60mls of the solution will be applied topically to the placental bed as identified by the surgeon carrying out the surgery by spraying the study solution using a syringe into the uterine cavity. Another 30mls of the solution will be applied to the open incision wound. The surgeon will then proceed to close the first layer of the uterus in the usual manner. The remaining 30mls of the study drug solution is then applied topically on the closed incision wound

Drug: Topical tranexamic acid

Control Group

SHAM COMPARATOR

Subjects in the Control group will receive topical normal saline solution which will be administered intra-operatively in the same manner as described for the TXA group.

Drug: Normal saline 0.9%

Interventions

Topical tranexamic acid DRUG

Topical tranexamic acid 2g diluted with normal saline 0.9% to a volume of 120mls solution (Concentration 16.7mg/ml)

Also known as: TXA group

Tranexamic acid (TXA) Group

Normal saline 0.9% DRUG

Sterile Normal saline 0.9% 120mls solution

Also known as: Control group

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parturients aged more than 18 years old
• American Society of Anesthesiologists (ASA) physical status class 1 to 3
• Parturients planned for caesarean sections (both emergency and elective) under regional anaesthesia
• Parturients who have increased risks of bleeding during caesarean deliveries as follows:
• Moderate Risk for Bleeding
• Induction of labour
• Prolonged labour \>12 hours
• Large baby \> 4kg
• Pyrexia in labour
• Age \> 40 years (not multiparous)
• Obesity (BMI \>35)
• Anaemia (Hb \< 9g/dl)
• Multigravida
• Previous history of PPH
• Previous scars

You may not qualify if:

• Parturients who have an urgent/emergency indication for caesarean sections where timing of the operation may be critical in determining the maternal and/or foetal outcomes
• Patients who are planned for caesarean sections under general anaesthesia
• Patients who are already clinically bleeding prior to surgery
• Parturients who received blood transfusion within 48 hours prior to the caesarean section
• Patients with known allergy to tranexamic acid
• Patients with clear contraindications for tranexamic acid (e.g. thromboembolic event, history of convulsions)
• Patients with severe renal failure with creatinine clearance \<10

Sponsors & Collaborators

• Dr Meng-Li Lee: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (1)

Hospital Tengku Ampuan Rahimah

Klang, Selangor, 41200, Malaysia

RECRUITING

Related Publications (16)

• AbouZahr C. Global burden of maternal death and disability. Br Med Bull. 2003;67:1-11. doi: 10.1093/bmb/ldg015.

  PMID: 14711750 BACKGROUND

• Al Kadri HM, Al Anazi BK, Tamim HM. Visual estimation versus gravimetric measurement of postpartum blood loss: a prospective cohort study. Arch Gynecol Obstet. 2011 Jun;283(6):1207-13. doi: 10.1007/s00404-010-1522-1. Epub 2010 May 28.

  PMID: 20508942 BACKGROUND

• Larsson C, Saltvedt S, Wiklund I, Pahlen S, Andolf E. Estimation of blood loss after cesarean section and vaginal delivery has low validity with a tendency to exaggeration. Acta Obstet Gynecol Scand. 2006;85(12):1448-52. doi: 10.1080/00016340600985032.

  PMID: 17260220 BACKGROUND

• Knight M, Callaghan WM, Berg C, Alexander S, Bouvier-Colle MH, Ford JB, Joseph KS, Lewis G, Liston RM, Roberts CL, Oats J, Walker J. Trends in postpartum hemorrhage in high resource countries: a review and recommendations from the International Postpartum Hemorrhage Collaborative Group. BMC Pregnancy Childbirth. 2009 Nov 27;9:55. doi: 10.1186/1471-2393-9-55.

  PMID: 19943928 BACKGROUND

• Ortmann E, Besser MW, Klein AA. Antifibrinolytic agents in current anaesthetic practice. Br J Anaesth. 2013 Oct;111(4):549-63. doi: 10.1093/bja/aet154. Epub 2013 May 9.

  PMID: 23661406 BACKGROUND

• Coats T, Roberts I, Shakur H. Antifibrinolytic drugs for acute traumatic injury. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD004896. doi: 10.1002/14651858.CD004896.pub2.

  PMID: 15495129 BACKGROUND

• Adler Ma SC, Brindle W, Burton G, Gallacher S, Hong FC, Manelius I, Smith A, Ho W, Alston RP, Bhattacharya K. Tranexamic acid is associated with less blood transfusion in off-pump coronary artery bypass graft surgery: a systematic review and meta-analysis. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):26-35. doi: 10.1053/j.jvca.2010.08.012. Epub 2010 Nov 5.

  PMID: 21115366 BACKGROUND

• Tzortzopoulou A, Cepeda MS, Schumann R, Carr DB. Antifibrinolytic agents for reducing blood loss in scoliosis surgery in children. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006883. doi: 10.1002/14651858.CD006883.pub2.

  PMID: 18646174 BACKGROUND

• Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.

  PMID: 19007970 BACKGROUND

• Novikova N, Hofmeyr GJ. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007872. doi: 10.1002/14651858.CD007872.pub2.

  PMID: 20614466 BACKGROUND

• Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, Mandelbrot L, Tillouche N, Fontaine S, Le Goueff F, Depret-Mosser S, Vallet B; EXADELI Study Group; Susen S. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15(2):R117. doi: 10.1186/cc10143. Epub 2011 Apr 15.

  PMID: 21496253 BACKGROUND

• Shakur H, Elbourne D, Gulmezoglu M, Alfirevic Z, Ronsmans C, Allen E, Roberts I. The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial. Trials. 2010 Apr 16;11:40. doi: 10.1186/1745-6215-11-40.

  PMID: 20398351 BACKGROUND

• Panteli M, Papakostidis C, Dahabreh Z, Giannoudis PV. Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. Knee. 2013 Oct;20(5):300-9. doi: 10.1016/j.knee.2013.05.014. Epub 2013 Jun 28.

  PMID: 23815893 BACKGROUND

• Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, McClelland B, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001886. doi: 10.1002/14651858.CD001886.pub2.

  PMID: 17943760 BACKGROUND

• Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD010562. doi: 10.1002/14651858.CD010562.pub2.

  PMID: 23881695 BACKGROUND

• Alshryda S, Sukeik M, Sarda P, Blenkinsopp J, Haddad FS, Mason JM. A systematic review and meta-analysis of the topical administration of tranexamic acid in total hip and knee replacement. Bone Joint J. 2014 Aug;96-B(8):1005-15. doi: 10.1302/0301-620X.96B8.33745.

  PMID: 25086114 BACKGROUND

Related Links

• The Millennium Developmental Goals Report 2008
• Postpartum Haemorrhage, Prevention and Management (Green-top Guideline No. 52)

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemorrhage

Interventions

Tranexamic Acid; Saline Solution; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Meng-Li Lee, FANZCA

  Department of Anaesthesia, Hospital Tengku Ampuan Rahimah, Ministry of Health, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng-Li Lee, FANZCA

CONTACT

+60165550499; leemengli@yahoo.com

Mohd Rohisham Zainal Abidin, MMed Anaes

CONTACT

+60122190123; drmrza@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Anaesthetist

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: July 8, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

MY (1)