Effects of transfusion of leukocyte-depleted erythrocytes in cardiac valve surgery on postoperative complications.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25360

Enrollment

496

Registered

2005-09-10

Start date

1999-05-01

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

Cardiac valve surgery +/- CABG.

Interventions

Randomization to receive buffy-coat-depleted (PC) or leukocyte-depleted transfusions when necessary. Pre-operative, at arrival at ICU and day 1 postoperatively at ICU blood samples were obtained.

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing valve surgery (+/- CABG).

Exclusion criteria

Exclusion criteria: Patients under 18 years of age, patients with medical indications for leucocyte-depleted erythrocytes and who received blood transfusions within previous 3 months.

Design outcomes

Primary

Measure	Time frame
90-days mortality and causes of deaths.	—

Secondary

Measure	Time frame
1. In-hospital mortality, 30- and 60-days mortality, onset and type of postoperative infections, onset and type of multiple-organ-dysfunction-syndrome (MODS), ICU-stay, hospital-stay and long-term survival. Pro-and anti-inflammatory cytokine profile, complement system activation and inflammatory mediators. 2. Cost-effective-analysis for the primary outcome.	—

Contacts

Public ContactY.M. Bilgin

Sanquin blood bank, Department of Research and Education, Plesmanlaan 1a

bilginyavuz@hotmail.com+31 (0)71 5685053

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)