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Age of Blood evalution.

Age of Blood evalution, resucitation in the critically ill.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25580
Enrollment
2000
Registered
2010-12-22
Start date
2011-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications occuring after red cell transfusion in ICU patients

Interventions

We 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 reci

Sponsors

Sanquin Blood bank Region South-West PO-box 2184 2301 CD Leiden The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: We 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 criteria

Exclusion criteria: 1. 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 patient’s 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).

Design outcomes

Primary

MeasureTime frame
In 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

MeasureTime frame
As 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.

Contacts

Public ContactE.K. Hogervorst

Plesmanlaan 1a

e.hogervorst@sanquin.nl+31 (0)71 5685068

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)