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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 22, 2009

Last Updated Date

April 8, 2009

Start Date ^†

April 2009

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00827931 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study

Condition ^†

Biliary Tract Surgical Procedures
Pancreaticoduodenectomy
Esophagectomy
Colectomy
Gastrectomy

Intervention ^†

Drug: Tranexamic acid + Standard of Care
Procedure: Standard of Care

Study Arms / Comparison Groups

Experimental: end of the operation and on the mornings of the first, second, fourth and seventh postoperative days.
Other: Standard of Care

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Estimated Enrollment ^†

Estimated Completion Date

October 2009

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00827931

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.