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. 2015 Dec 3;2015(12):CD009745. doi: 10.1002/14651858.CD009745.pub2

van de Watering 1998.

Methods Design: Parallel group RCT
Country: The Netherlands
Multicentre study: No
Setting: Hospital
Follow‐up: 60 days after surgery
Unit of allocation: Patients
Unit of analysis: Patients
Participants Inclusion criteria: Adults patients undergoing Coronary Artery Bypass grafting (CAGB) surgery, cardiac valve surgery or a combination of both, who had not received blood within the last 6 months.
Exclusion criteria: None clearly reported

  • Patients enrolled: 944

  • Patients randomised: 914


Packed cells without buffy coat: 306
Fresh‐filtered units: 305
Stored‐filtered units: 303

  • Patients transfused: 866

  • Patients considered for the analysis: 914


Main characteristics of patients:
Age: Standard packed cells without buffy coat group = 64.4 ± 9.5 years; Fresh‐filtered units group = 62.9 ± 9.8 years. Stored‐filtered units group = 63.3 ± 9.1 years
Percentage of men: Standard packed cells without buffy coat group = 72%; Fresh‐filtered units group = 74%. SF group = 68%
Percentage of history of myocardial infarction: Standard packed cells without buffy coat group = 50.3%; Fresh‐filtered units group = 44.6%. Stored‐filtered units group = 46.4%
Preoperative Hb: Standard packed cells without buffy coat group = 8.8 ± 0.9 mmol/L; Fresh‐filtered units group = 8.9 ± 0.9 mmol/L. Stored‐filtered units group = 8.8 ± 0.9 mmol/L
Postoperative Hb: Standard packed cells without buffy coat group = 6.6 ± 0.7 mmol/L; Fresh‐filtered units group = 6.6 ± 0.7 mmol/L. Stored‐filtered units group = 6.5 ± 0.7 mmol/L
Interventions

  1. PC trial arm: Standard packed cells without buffy coat.

  2. FF trial arm: Fresh‐filtered units (pre‐storage leukoreduction).

  3. SF trial arm: Stored‐filtered units (post‐storage leukoreduction).


Cointervention: Quote: "Antibiotic prophylaxis was given for 24 hours with CABG and for 48 hours with valve or combined surgery" (Page 563).
Outcomes

  1. Primary:

    1. Incidence of postoperative infections.

    2. HLA antibody formation.

  2. Secondary:

    1. Duration of hospitalisations.

    2. Postoperative mortality within 60 days.

    3. Other postoperative complications.
Notes Trial registration: Not reported
Funding: NPBI bv, Emmer‐Compascuum, The Netherlands
Role of sponsor: Not reported
A priori sample size estimation: unclear. Trial authors reported the only two criteria for sample size calculation (the proportion expected in each group). The dropout rate expected is not reported.
Conducted: Between March 1992 and August 1994
Declared conflicts of interest: Not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "patients were, by means of a randomizations list at the hospital transfusion service, randomly allocated..." (Page 563).
Allocation concealment (selection bias) Unclear risk Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "The surgeons and anesthetists were blind to the randomizations result" (Page 563).
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "The surgeons and anesthetists were blind to the randomization result" (Page 563).
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: All patients transfused were analysed (Page 567).
Selective reporting (reporting bias) Low risk The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified.
Other bias Low risk