Skip to main content
. 2015 Dec 3;2015(12):CD009745. doi: 10.1002/14651858.CD009745.pub2

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
Participants Inclusion criteria: Patients admitted for elective colorectal surgery
Exclusion criteria: < 18 years of age, need for emergency surgery, or immunosuppressive treatment, except steroids
  • Patients enrolled: 589

  • Patients randomised: 589


Leucocyte‐depleted red cells group: 290
Buffy‐coat‐poor red cells group: 299
  • Patients transfused: 260

  • Patients considered for the analysis: 586


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.
Interventions
  1. Leucocyte‐depleted red cells group (the timing of leukoreduction is not reported).

  2. Buffy‐coat‐poor red cells group.


Cointervention:
Quote: "All patients received an intravenous dose of cefuroxime 3 g and metronidazole 1.5 g after induction of anaesthesia" (Page 842).
Outcomes This RCT did not specify by primary or secondary outcomes.
  1. Abdominal wound infection: Accumulation of pus with spontaneous discharge or requiring surgical drainage.

  2. Deep surgical infection: Intraabdominal abscess or septicaemia.

  3. Pneumonia: Fever and infiltrate on chest radiography.

  4. Surgical complications: Anastomotic leakage, abdominal wound dehiscence, intra‐abdominal bleeding and ileus.

  5. Operation‐related mortality: Death during hospital stay or within 30 days after surgery.

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.
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.