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Trial record 36 of 419 for:    TRANEXAMIC ACID

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

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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
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr Bikal Ghimire, Tribhuvan University Teaching Hospital, Institute Of Medicine.

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.


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

  Show Detailed Description

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Outcome Measures :
  1. 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 :
  1. Secondary outcome measure [ Time Frame: 30days ]
    Re-bleeding events

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

  3. Secondary outcome measure [ Time Frame: 30 days ]
    Length of stay in ICU



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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

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
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Nepal
Tribhuvan University Teaching Hospital
Kathmandu, Kathmandy, Nepal, 0977
Sponsors and Collaborators
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Pfizer
Investigators
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Principal Investigator: Bikal Ghimire, MS Tribhuvan University, Nepal

Publications of Results:

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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:
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Tranexamic Acid
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants