Jensen 1996.
Methods | Design: Parallel group RCT Country: Denmark Multicentre study: Yes (2 university departments of colorectal surgery; page 844). Setting: Hospital Follow‐up: 30 days after surgery Unit of allocation: Patients Unit of analysis: Patients |
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Participants | Inclusion criteria: Patients admitted for elective colorectal surgery Exclusion criteria: < 18 years of age, need for emergency surgery, or immunosuppressive treatment, except steroids
Leucocyte‐depleted red cells group: 290 Buffy‐coat‐poor red cells group: 299
Main characteristics of patients: Age = Median (range): Leucocyte‐depleted red cells group = 69 (35 to 89) years; Buffy‐coat‐poor red cells group = 68 (29 to 92) years Percentage of men: Leucocyte‐depleted red cells group = 50%; buffy‐coat‐poor red cells group = 48% Number of procedures: Sigmoid resection: Leucocyte‐depleted red cells group = 11; Buffy‐coat‐poor red cells group = 19 Blood loss = Median (range): Leucocyte‐depleted red cells group = 715 (50 to 3500) mL; Buffy‐coat‐poor red cells group = 805 (10 to 4300) mL. |
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Interventions |
Cointervention: Quote: "All patients received an intravenous dose of cefuroxime 3 g and metronidazole 1.5 g after induction of anaesthesia" (Page 842). |
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Outcomes | This RCT did not specify by primary or secondary outcomes.
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Notes | Trial Registration: Not reported. Funding: Not reported. Role of sponsor: Not stated. A priori sample size estimation: Yes. Conducted: Between January 1992 and January 1995. Declared conflicts of interest: Not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "were randomly allocated using sealed envelopes to receive either..." (Page 841). Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’. |
Allocation concealment (selection bias) | Unclear risk | Quote: "were randomly allocated using sealed envelopes to receive either..." (Page 841) Use of opaque envelopes is not reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Insufficient information to permit judgement of ‘low risk’ or ‘high risk’. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Physicians who were blinded to the transfusion protocol performed follow‐up examinations..." (Page 842). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: All patients transfused were analysed. (Page 842). |
Selective reporting (reporting bias) | Low risk | Comment: 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 | Unclear risk | Comment: Sample size estimation took into account loss to follow‐up due to no transfusion. |