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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Dr Bikal Ghimire, Tribhuvan University Teaching Hospital, Institute Of Medicine..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01655641
First Posted: August 2, 2012
Last Update Posted: October 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr Bikal Ghimire, Tribhuvan University Teaching Hospital, Institute Of Medicine.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Dr Bikal Ghimire, 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 ]

Secondary Outcome Measures:
  • Secondary outcome measure [ Time Frame: 30days ]
    Re-bleeding events

  • Secondary Outcome measure [ Time Frame: 30 days ]
    Need for surgical intervention

  • Secondary outcome measure [ Time Frame: 30 days ]
    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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 23, 2012
First Posted: August 2, 2012
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by Dr Bikal Ghimire, 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