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Transfusion-requirements in Septic Shock Trial

NCT01485315 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1005

Last updated 2014-10-03

No results posted yet for this study

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

Conditions

  • Septic Shock

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

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

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

Sponsors & Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Scandinavian Critical Care Trials Group

    lead OTHER

Principal Investigators

  • Anders Perner, MD, PhD · Dept. of Intensive Care, Rigshospitalet / SCCTG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • Denmark
  • Finland
  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01485315 on ClinicalTrials.gov