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

Boshkov 2006.

Methods Design: Parallel group RCT
Country: USA
Multicentre study: Yes (three centre trial)
Setting: Hospital
Follow‐up: 2 to 12 months
Unit of allocation: Patients
Unit of analysis: Patients
Participants Inclusion criteria:
  • Undergoing coronary artery bypass grafting, cardiac valve replacement or a combination of the two.


Exclusion criteria: Not reported in the abstract
  • Patients enrolled: Not clearly reported in the abstract.

  • Patients randomised: 1226.


Prestorage leukoreduced RBC (LR‐RBCs): The number of patients is not clearly reported in the abstract.
Standard RBCs (S‐RBCs): The number of patients is not clearly reported in the abstract.
  • Patients transfused: 562.

  • Patients considered for the analysis: Not clearly reported in the abstract.


Main characteristics of patients:
"Groups were statistically equivalent demographically and by all Society of Thoracic Surgery risk criteria".
Interventions
  1. Experimental: LR‐RBCs (pre‐storage leukoreduction).

  2. Control: S‐RBCs.


Co‐intervention: not reported in the abstract
Outcomes Primary:
  1. Operative and postoperative mortality at 60 days after surgery.


Secondary: Not reported in the abstract.
Notes Trial registration: Not reported in the abstract
Funding: Not reported in the abstract
Role of sponsor: Not reported in the abstract
A priori sample size estimation: Not reported in the abstract
Conducted: Not reported in the abstract
Declared conflicts of interest: "No relevant conflicts of interest to declare" (reported in the abstract)
Other relevant information: All study characteristics were obtained from the abstract. We tried to contact two trial authors by email, but no response has not yet been obtained
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "patients (undergoing coronary artery bypass grafting, cardiac valve replacement, or a combination of the two) were pre‐operatively randomised to receive either LR‐ or S‐RBCs (Abstract).
Insufficient information to permit judgement of ‘low risk’ or ‘high risk’.
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: "Patients and clinicians were blinded as to product type" (Abstract).
The blinding methods are not clearly reported.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Patients and clinicians were blinded as to product type" (Abstract).
Comments: No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk "562 patients (45.8%) were transfused: 304 received LR‐RBCs and 258 S‐RBCs" (Abstract)
Loss after transfusion: Not reported in the abstract
Loss after transfusion LR group: Not reported in the abstract
Loss after transfusion Control group: Not reported in the abstract
Loss after transfusion. Imbalance between comparison groups: Not reported in the abstract.
Comment: Insufficient reporting of attrition/exclusions to permit judgement of ‘low risk’ or ‘high risk’ (e.g. number randomised not stated, no reasons for missing data provided).
Selective reporting (reporting bias) Unclear risk Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’ (Abstract data).
Other bias High risk Design bias: 1226 patients randomised; only 562 (45.8) were transfused.