CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 94 enrolled
Drug / intervention
Tranexamic acid + Standard of Care +1 moredrug
Likely dose
Tranexamic acid + Standard of Care 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00827931
NCT00827931Phase 4Completed

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

Pfizer·interventional·Posted Jan 23, 2009·Updated Apr 26, 2012

In Brief

A Phase 4 clinical trial evaluating Tranexamic acid + Standard of Care and Standard of Care for Biliary Tract Surgical Procedures and 4 related conditions. Completed, enrolled 94 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2009
Enrollment StartSep 1, 2009
Primary CompletionApr 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.4 years ago

Interventions

Tranexamic acid + Standard of Caredrug

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)

Standard of Careprocedure

Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss