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

This study is ongoing, but not recruiting participants.
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
  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:


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.
Other Name: Standard of care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
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:

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:
Colonic Neoplasms
Liver Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Liver Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014