Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00827931

Purpose

Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus standard of care versus standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.

Condition	Intervention	Phase
Biliary Tract Surgical Procedures Pancreaticoduodenectomy Esophagectomy Colectomy Gastrectomy	Drug: Tranexamic acid + Standard of Care Procedure: Standard of Care	Phase IV

MedlinePlus related topics: Surgery

Drug Information available for: Tranexamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Vs Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate the efficacy of tranexamic acid plus standard of care compared to standard of care on the reduction in postoperative blood loss [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intra-operative blood loss. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Total blood loss [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Total blood loss as assessed by Gross' formula [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Number of patients receiving transfusions [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Post-operative hemoglobin levels [ Time Frame: end of the operation and on the mornings of the first, second, fourth and seventh postoperative days ] [ Designated as safety issue: No ]
Post-operative incidence of deep vein thrombosis [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	94
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.	Drug: Tranexamic acid + Standard of Care Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss)
B Standard of Care	Procedure: Standard of Care Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients undergoing major abdominal surgery (Biliary strictures, Pancreatic-duodenectomy, Esophagectomy, Total proctocolectomy, Hemicolectomy, Gastrectomy)

Exclusion Criteria:

Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia.
Patients with known coagulopathy.
Patients with anemia (hemoglobin levels less than 8 mg/dl)
Patients with documented DVT or PE at screening or in past three months.
Patients with any associated major illness (e.g., severe cardiac or respiratory disease).
Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827931

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1461001
Study First Received:	January 22, 2009
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00827931 History of Changes
Health Authority:	India: Institutional Review Board

Keywords provided by Pfizer:

tranexamic acid major abdominal surgery blood loss

Study placed in the following topic categories:

Fibrin Modulating Agents
Antiplasmin
Antifibrinolytic Agents
Anesthetics

Tranexamic Acid
Hemorrhage
Hemostatics

Additional relevant MeSH terms:

Fibrin Modulating Agents
Antifibrinolytic Agents
Coagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Tranexamic Acid
Hemostatics
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009