CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,005 enrolled
Drug / intervention
SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion +1 morebiological
Likely dose
SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion 9.0 gfrom 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/NCT01485315
NCT01485315Phase 3Completed

Effects of Red Blood Cell Transfusion on Mortality and Morbidity in Patients With Septic Shock

Scandinavian Critical Care Trials Group·interventional·Posted Dec 5, 2011·Updated Oct 3, 2014

In Brief

A Phase 3 clinical trial evaluating SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion for Septic Shock. Completed, enrolled 1,005 participants across 32 sites in 4 countries.

Detailed Summary

Patients with blood poisoning - sepsis - often receive blood transfusions in the intensive care unit. The evidence that blood transfusion leads to improved outcome is limited and the blood may be harmful to some of these patients. To bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of RBC transfusion in these very sick patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
CountriesDenmark, Finland, Norway, Sweden

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2011
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.6 years ago

Interventions

SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusionbiological

One unit prestorage, leuko-depleted SAGM blood at haemoglobin at 9.0 g/dl (5.6 mM) or less at point-of-care testing

SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusionbiological

One unit prestorage, leuko-depleted SAGM blood at haemoglobin 7.0 g/dl (4.3 mM) or less at point-of-care testing