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Tracking Information | |||||
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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 † |
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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. |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Not yet recruiting | ||||
Estimated Enrollment † | 94 | ||||
Estimated Completion Date | October 2009 | ||||
Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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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 † |
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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. |