CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 198 enrolled
Drug / intervention
Red blood cell transfusion +1 moreother
Likely dose
Not stated in 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/NCT01502215
NCT01502215Phase 3Completed

Transfusion Requirements in Surgical Oncologic Patient

University of Sao Paulo·interventional·Posted Dec 30, 2011·Updated Dec 5, 2012

In Brief

A Phase 3 clinical trial evaluating Red blood cell transfusion for Red Blood Cells Transfusion and Oncologic Surgery. Completed, enrolled 198 participants across 1 site.

Detailed Summary

Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 30, 2011
Enrollment StartJan 1, 2012
Primary CompletionOct 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.5 years ago

Interventions

Red blood cell transfusionother

Red blood cell (RBC) transfusion will be given when hemoglobin fall below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hemoglobin levels is performed;if a patient's hemoglobin is 9 g/dL or higher, no additional transfusion is necessary.

Red blood cell transfusionother

Red blood cell (RBC) transfusion will be only given when hemoglobin fall below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hemoglobin 7 g/dL or higher, no additional transfusion is necessary