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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2012 by Tribhuvan University Teaching Hospital, Institute Of Medicine..
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Dr Bikal Ghimire, Tribhuvan University Teaching Hospital, Institute Of Medicine.

ClinicalTrials.gov Identifier:

NCT01655641

First received: July 23, 2012

Last updated: October 14, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Gastric Cancer Pancreatic Cancer Hepatocellular Cancer Colon Cancer	Drug: Tranexamic acid Other: Standard of care	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Role of Tranexamic Acid for Reducing Blood Loss in Patients Undergoing Major Gastro-intestinal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Blood Transfusion and Donation

Drug Information available for: Tranexamic acid

Genetic and Rare Diseases Information Center resources: Stomach Cancer Liver Cancer

U.S. FDA Resources

Further study details as provided by Tribhuvan University Teaching Hospital, Institute Of Medicine.:

Primary Outcome Measures:

Primary objective of the study is to compare transfusion requirements and Mortality in patients receiving Tranexamic acid (Cyklokapron®) and those not receiving it. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary outcome measure [ Time Frame: 30days ] [ Designated as safety issue: Yes ]
Re-bleeding events
Secondary Outcome measure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Need for surgical intervention
Secondary outcome measure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Length of stay in ICU


Estimated Enrollment:	118
Study Start Date:	July 2012
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tranexamic acid arm 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 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) Other Name: Cyklokapron®
Active Comparator: Standard of care arm Includes routine surgical care involved in preventing blood loss during and after surgery.	Other: Standard of care Includes routine surgical care involved in preventing blood loss during and after surgery.

Arms

Assigned Interventions

Experimental: Tranexamic acid arm

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

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)

Other Name: Cyklokapron®

Active Comparator: Standard of care arm

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

Other: Standard of care

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

Show Detailed Description

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients undergoing major GI surgery that includes resection of:

Esophagus
Stomach
Spleen
Liver
Pancreas
Colon

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655641

Locations


Nepal
Tribhuvan University Teaching Hospital
Kathmandu, Kathmandy, Nepal, 0977

Sponsors and Collaborators

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Pfizer

Investigators


Principal Investigator:	Bikal Ghimire, MS	Tribhuvan University, Nepal

More Information

Publications:

Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl J Med. 2007 May 31;356(22):2301-11. Review.

Blajchman MA, Vamvakas EC. The continuing risk of transfusion-transmitted infections. N Engl J Med. 2006 Sep 28;355(13):1303-5.

Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. Review.

Colomina MJ, Bagó 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.

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.

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.

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. Review. Update in: Cochrane Database Syst Rev. 2011;(1):CD001886.

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.

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, Mejía-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.

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.

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.

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.

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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.

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.


Responsible Party:	Dr Bikal Ghimire, Assistant Professor, Tribhuvan University Teaching Hospital, Institute Of Medicine.
ClinicalTrials.gov Identifier:	NCT01655641 History of Changes
Other Study ID Numbers:	# WS2017115
Study First Received:	July 23, 2012
Last Updated:	October 14, 2012
Health Authority:	Nepal: Institutional Review Board

Keywords provided by Tribhuvan University Teaching Hospital, Institute Of Medicine.:


Blood transfusion Bleeding Major Gastro-intestinal surgery Tranexamic Acid

Additional relevant MeSH terms:


Pancreatic Neoplasms Stomach Neoplasms Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases	Gastrointestinal Neoplasms Gastrointestinal Diseases Stomach Diseases Liver Diseases Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants

ClinicalTrials.gov processed this record on September 30, 2016

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