CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 82 enrolled
Drug / intervention
Tranexamic Acid plus standard of care +1 moredrug
Likely dose
Tranexamic Acid plus 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/NCT00824564
NCT00824564Phase 4Completed

Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture

Pfizer·interventional·Posted Jan 16, 2009·Updated Jun 28, 2011

In Brief

A Phase 4 clinical trial evaluating Tranexamic Acid plus standard of care and Standard of care for Femoral Fractures. Completed, enrolled 82 participants across 1 site.

Detailed Summary

Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.

Study Details

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

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2009
Enrollment StartApr 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.5 years ago

Interventions

Tranexamic Acid plus 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