Study of Tranexamic Acid for Reducing Blood Requirement in Patients Undergoing Major Gastro-intestinal Surgery

NCT01655641 | Unknown Phase 2 DMC

• 1 other identifier: # WS2017115
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective of the study is to compare requirement of blood transfusion and mortality in patients receiving Tranexamic acid (Cyklokapron®) and those not receiving it. Secondary objective is to; assess the re-bleeding events; need for surgical intervention; length of stay in Intensive care unit in between the two groups.

Conditions

Gastric Cancer; Pancreatic Cancer; Hepatocellular Cancer; Colon Cancer

Keywords

Blood transfusion; Bleeding; Major Gastro-intestinal surgery; Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• Primary objective of the study is to compare transfusion requirements and Mortality in patients receiving Tranexamic acid (Cyklokapron®) and those not receiving it.

  30 days

Secondary Outcomes (3)

• Secondary outcome measure

  30days

• Secondary Outcome measure

  30 days

• Secondary outcome measure

  30 days

Study Arms (2)

Tranexamic acid arm

EXPERIMENTAL

Along with the standard of care (routine surgical care involved in preventing blood loss during surgery) this arm will receive drug Tranexamic acid 1gm stat, preoperatively (30 mins) 10mg / kg body weight, 8 hourly for 5 days via IV for non-renal impaired subjects. Alternate IV dosing for renally-impaired subjects: 10mg/Kg BID (1.36 - 2.83 mg/dl clearance); 10mg/Kg QD (2.84 - 5.66 mg/dl clearance; and 10mg/Kg Q48H or 5mg/Kg (.5.66mg/dl clearance)

Drug: Tranexamic acid

Standard of care arm

ACTIVE COMPARATOR

Includes routine surgical care involved in preventing blood loss during and after surgery.

Other: Standard of care

Interventions

Tranexamic acid DRUG

Drug: Tranexamic acid 1gm stat, preoperatively (30 mins) 10mg / kg body weight, 8 hourly for 5 days via IV For non-renal impaired subjects. Alternate IV dosing for renally-impaired subjects: 10mg/Kg BID (1.36 - 2.83 mg/dl clearance); 10mg/Kg QD (2.84 - 5.66 mg/dl clearance; and 10mg/Kg Q48H or 5mg/Kg (.5.66mg/dl clearance)

Also known as: Cyklokapron®

Tranexamic acid arm

Standard of care OTHER

Includes routine surgical care involved in preventing blood loss during and after surgery.

Standard of care arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing major GI surgery that includes resection of:
• Esophagus
• Stomach
• Spleen
• Liver
• Pancreas
• Colon

You may not qualify if:

• Pre op HB less than 10mg/dl
• Pregnant or lactating women
• On anticoagulation therapy
• Patients with history of thromboembolism
• Patients with history of myocardial infarction or ischemic cerebrovascular accident
• Patient with end stage renal disease
• Patients with DNR status
• Patients with known bleeding abnormalities
• Emergency/unplanned surgeries
• Patients with known allergy/contraindications to Tranexamic acid
• Patients not capable of giving consent for medical reasons (psychiatric etc)\\
• Patients not giving consent or opting to withdraw from the study

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead
• Pfizer: collaborator

Study Sites (1)

Tribhuvan University Teaching Hospital

Kathmandu, Kathmandy, 0977, Nepal

Location

Related Publications (14)

• Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl J Med. 2007 May 31;356(22):2301-11. doi: 10.1056/NEJMra067742. No abstract available.

  PMID: 17538089 RESULT

• Blajchman MA, Vamvakas EC. The continuing risk of transfusion-transmitted infections. N Engl J Med. 2006 Sep 28;355(13):1303-5. doi: 10.1056/NEJMp068178. No abstract available.

  PMID: 17005947 RESULT

• Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.

  PMID: 10400410 RESULT

• Colomina MJ, Bago J, Fuentes I. Efficacy and safety of prophylactic large dose of tranexamic acid in spine surgery: a prospective, randomized, double-blind, placebo-controlled study. Spine 2008; 33: 2577-80. Spine (Phila Pa 1976). 2009 Jul 15;34(16):1740-1; author reply 141. doi: 10.1097/BRS.0b013e3181a9ce1f. No abstract available.

  PMID: 19770617 RESULT

• Elwatidy S, Jamjoom Z, Elgamal E, Zakaria A, Turkistani A, El-Dawlatly A. Efficacy and safety of prophylactic large dose of tranexamic acid in spine surgery: a prospective, randomized, double-blind, placebo-controlled study. Spine (Phila Pa 1976). 2008 Nov 15;33(24):2577-80. doi: 10.1097/BRS.0b013e318188b9c5.

  PMID: 19011538 RESULT

• Urban MK, Beckman J, Gordon M, Urquhart B, Boachie-Adjei O. The efficacy of antifibrinolytics in the reduction of blood loss during complex adult reconstructive spine surgery. Spine (Phila Pa 1976). 2001 May 15;26(10):1152-6. doi: 10.1097/00007632-200105150-00012.

  PMID: 11413430 RESULT

• 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 RESULT

• Katsaros D, Petricevic M, Snow NJ, Woodhall DD, Van Bergen R. Tranexamic acid reduces postbypass blood use: a double-blinded, prospective, randomized study of 210 patients. Ann Thorac Surg. 1996 Apr;61(4):1131-5. doi: 10.1016/0003-4975(96)00022-7.

  PMID: 8607670 RESULT

• 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 RESULT

• Crescenti A, Borghi G, Bignami E, Bertarelli G, Landoni G, Casiraghi GM, Briganti A, Montorsi F, Rigatti P, Zangrillo A. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011 Oct 19;343:d5701. doi: 10.1136/bmj.d5701.

  PMID: 22012809 RESULT

• Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992 May;111(5):518-26.

  PMID: 1598671 RESULT

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 RESULT

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 RESULT

• American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Practice guidelines for perioperative blood transfusion and adjuvant therapies: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Anesthesiology. 2006 Jul;105(1):198-208. doi: 10.1097/00000542-200607000-00030. No abstract available.

  PMID: 16810012 RESULT

MeSH Terms

Conditions

Stomach Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Colonic Neoplasms; Hemorrhage

Interventions

Tranexamic Acid; Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bikal Ghimire, MS

  Tribhuvan University, Nepal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: August 2, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2014
• Last Updated: October 16, 2012

Record last verified: 2012-10

Locations

NE (1)