Age of Blood Evaluation, resuscitation in the critically ill

Completed

Conditions: overall clinical outcome in ICU patients
90 day mortality
mortality rate in ICU
transfusion reaction

Registration Number: NL-OMON39346

Lead Sponsor: Sanquin Bloedbank

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 450

Inclusion Criteria

1) The need of a first red cell unit transfusion in the first 7 days of ICU admittance (or in the emergency department after admission to the ICU was requested by an intensivist),
2) an anticipated length of invasive and/or non-invasive mechanical ventilation of at least 48 hours once enrolled, as estimated by the attending physician.
3) age >18 years

Exclusion Criteria

Exclusion criteria ABLE:
- Age below 18
- Suspection (written or otherwise) of a previous red cell transfusion during the current admitance
- Preexisting terminal illness with a life expectancy < 3 months
- Patients who undergo routine elective ( cardiothoracic) surgery during the same hospitalisation
- Patients who have treatment restrictions other then a DNR at the time of randomization
- Patients who are declared braindead
- Patients who have moral or religious reasons to refuse a red cell transfusion
- Patients who received autologous blood
- Patients who are included in an other study
- Patients whose physician refuses to include him/her
- Patients who have previously participated in the ABLE study
- Patients who received more then one unit of uncross-matched blood
- When supplying the right randomised red cell unit causes logistical problems

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primary outcome in the ABLE study is the 90 day mortality. We hope to<br /><br>achieve an absolute risk reduction in the 90 day mortality of 5%.<br /><br><br /><br>Additional endpoints for the VuMC substudy:<br /><br>Capillary density, Mean flow index, the proportion of perfused vessels (PPV),<br /><br>perfused vessel density (PVD), tissue oxygenatie.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints ABLE study<br /><br>1) In hospital mortality, mortality during ICU admittance, mortality at 28 days<br /><br>and after 6 months.<br /><br>2) MODS and the severity of organ failure determined by the MODS score<br /><br>3) nosocomial infections<br /><br>4) Length of stay in the ICU<br /><br>5) Lenght of hospital stay<br /><br>6) transfusion reactions</p><br>