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van CCT (UK)

van CCT (UK)

Age of Blood evalution.

- candidate number8810
- NTR NumberNTR2662
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2010
- Secondary IDs 
- Public TitleAge of Blood evalution.
- Scientific TitleAge of Blood evalution, resucitation in the critically ill.
- hypothesisWe hypothesize that transfusing red cells with a storage time of 2 to 8 days reduces the incidence of nosocomial pneumonia in ICU patients.
- Healt Condition(s) or Problem(s) studiedIntensive Care (IC) patients, Complications, Red cell transfusion
- Inclusion criteriaWe will include patients who:
1. Have had a request for a first red cell unit transfusion in the ICU (or in the emergency department after admission to the ICU was requested by an intensivist), and;
2. Have an anticipated length of invasive and/or non-invasive mechanical ventilation of at least 24 hours, once enrolled, as estimated by the attending physician.
- Exclusion criteria1. Less than 18 years of age;
2. For whom there is verbal or written report of a red cell transfusion during the current hospitalisation (including time in emergency room and/or during transport in ambulance and/or time in another hospital prior to the transfer, whatever the length of the first hospitalization is);
3. Who have an obvious terminal illness documented in the medical record with a life expectancy less than 3 months;
4. Where a decision to withdraw/withhold some care has been made (Patients who have a DNR but no other treatment restrictions can be included!);
5. Is obviously brain dead;
6. Who have a known objection to blood transfusion;
7. Who had a transfusion with autologous donation of blood;
8. Who is already enrolled in a competing trial;
9. Whose attending intensivist refused patientís participation in the ABLE study.

Blood bank personnel will also exclude:
1. Patients who were previously enrolled in the ABLE study;
2. When there are no available red cells with storage time of 7 days or less compatible with this patient blood group in the blood bank and that cannot be transported from the blood supplier;
3. Patients who require more than 1 unit of uncross-matched cells, who pose difficulties in securing blood products (rare blood groups or difficult to crossmatch).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2011
- planned closingdate1-mrt-2014
- Target number of participants2000
- InterventionsWe will randomise ICU patients in need for a red cell transfusion into two arms. One arm will receive red cells according to standard procedure (storage time 2 - 35 days) while the other arm will recieve "fresher" red cells (storage time: 2-8 days).
- Primary outcomeIn the ABLE-NL study the primary analysis will be on nosocomial infections, especially pneumonia. Pneumonia is the only clinical endpoint that has been reported more than once to remain statistically significantly correlated with storage time, even after adequate correction for total number of RBC transfusions. Increases in pneumonia of up to 6% for each additional day of storage have been reported.
- Secondary outcomeAs compared to standard issue red cells, we will ascertain whether red cells stored 7 days or less:
1. Decrease in-hospital, ICU, 28-day, 90-day and 6-month mortality;
2. Decrease the severity of multiple organ dysfunction syndrome (MODS), as measured by the number of organ dysfunction and MODS score;
3. Decrease serious nosocomial infections;
4. Reduce the length of ICU and hospital stays;
5. The occurence of alloimmunisation after transfuion of red cells.
Special attention will also be paid to red cell transfusions and transfusion reactions.
- Timepoints1. Feb 2011: Approval METC;
2. March 2011: Start including patients;
3. Jan 2014: Stop inclusion;
3. 2014: Presentation and publication.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Sanquin Blood Bank South West Region
- Funding
(Source(s) of Monetary or Material Support)
Sanquin Blood Supply, ABLE study group - Canada
- PublicationsN/A
- Brief summaryABLE-NL is a branch of the multicenter international dubbelblind RCT founded in Canada. The international ABLE study ascertains whether storage time is of any influence on the 90-day all-cause mortality in critically ill ICU patients. The ABLE-NL has as its own primary endpoint the incidence of pneumonia in ICU patientes after they received "fresh" versus standard procedure red cell transfusion besides including dutch patients for the international ABLE study.
- Main changes (audit trail)
- RECORD22-dec-2010 - 3-jan-2011

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