Study of Tranexamic Acid for Reducing Blood Requirement in Patients Undergoing Major Gastro-intestinal Surgery (TMGS)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01655641 |
Recruitment Status
: Unknown
Verified October 2012 by Dr Bikal Ghimire, Tribhuvan University Teaching Hospital, Institute Of Medicine..
Recruitment status was: Active, not recruiting
First Posted
: August 2, 2012
Last Update Posted
: October 16, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer Pancreatic Cancer Hepatocellular Cancer Colon Cancer | Drug: Tranexamic acid Other: Standard of care | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 118 participants |
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 |
Study Start Date : | July 2012 |
Estimated Primary Completion Date : | June 2013 |
Estimated Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
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.
|
- 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 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Nepal | |
Tribhuvan University Teaching Hospital | |
Kathmandu, Kathmandy, Nepal, 0977 |
Principal Investigator: | Bikal Ghimire, MS | Tribhuvan University, Nepal |
Publications of Results:
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 Posted: | August 2, 2012 Key Record Dates |
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 |