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

Collier 2001.

Methods Design: Parallel group RCT
Country: USA
Multicentre study: Yes (11 academic medical centres)
Setting: Hospital
Follow‐up: 12 months
Unit of allocation: Patients
Unit of analysis: Patients
Participants Inclusion criteria:
Those 14 years of older, with confirmed HIV infection and documented CMV infection (by chart or antibody testing), Karnofsky performance score of ≥ 40, expected survival of more than 1 month, symptomatic anaemia requiring red blood concentrates transfusion and no received transfusions within 72 hours of enrolment.
Exclusion criteria:
Those with a surgical reason for transfusion, a priori history for transfusion, renal failure requiring dialysis, thrombocytopenic purpura, used intravenous immunoglobulin within 6 weeks of entry or those that had started new antiretroviral drugs or systematic immunomodulators within 2 weeks of entry.

  • Patients enrolled: 531.

  • Patients randomised: 531.


Leukoreduced red blood concentrates transfusion: 265
Unmodified red blood concentrates transfusion: 266

  • Patients transfused: 521.

  • Patients considered for the analysis: 470.


Main characteristics of patients:
Age: Leukoreduced group = 38.3 ± 8.2 years; Unmodified group = 38.4 ± 8.3 years
Percentage of men: Leukoreduced group = 79%; Unmodified group = 79%
Percentage of antiretroviral therapy‐potent combination: Leukoreduced group = 27%; Unmodified group = 22%
Karnofsky score: Leukoreduced group = 71.4 ± 13.2; Unmodified group = 70.9 ± 12.8
CD4 cells/μL, median: Leukoreduced group = 16 (3 to 71.5); Unmodified group = 12.5(4 to 76)
Interventions

  1. Experimental: Leukoreduced RBC transfusion (pre‐storage leukoreduction)

  2. Control: Unmodified RBC transfusion.


Cointervention: Leukoreduced platelets if was required.
Outcomes

  1. Primary (changed 3 months after beginning of study):

    1. Survival. "...additional resources were obtained to increase accrual to 640 and change the primary clinical end point to survival" (Page 1594).

  2. Secondary:

    1. Time to death.

    2. First serious HIV‐related complication (including specific AIDS‐defining conditions and serious bacterial infections associated with median survival times of < 1 year or an acute mortality > 5%).

    3. Time to new or progressive CMV end organ disease.

    4. Plasma HIV RNA and CMV DNA levels.

    5. Lymphocyte subset markers.

    6. Change in cytokine and lymphocyte activation markers.
Notes Trial registration: Not reported
Funding: This study was financially supported by Roche Molecular systems and National Heart, Lung and Blood Institute (contract RR00046) (Page 1600).
Role of sponsor: Reagents: Funding/Support: Reagents for detection and quantitation of CMVDNA by polymerase chain reaction were contributed by Roche Molecular Systems (Alameda,Calif). Support provided by National Heart was not detailed
A priori sample size estimation: Yes
Conducted: July 1995 through June 1999
Declared conflicts of interest: Trial authors received research funding from Roche
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The study was a randomised, double blind, comparative study" (Page 1593).
Quote: "Treatment allocation was made centrally by the study coordinating center, using stratified permuted blocks with dynamic balancing within each center" (Page 1593).
Allocation concealment (selection bias) Low risk Quote: "Treatment allocation was made centrally by the study coordinating center, using stratified permuted blocks with dynamic balancing within each center" (Page 1593).
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "The participants, investigators, study coordinators, and persons having any contact with the patients were blinded to study treatment assignments. Blood bank technical staff who prepared the blood products were aware of the treatment assignments" (Page 1593).
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "The participants, investigators, study coordinators, and persons having any contact with the patients were blinded to study treatment assignments. Blood bank technical staff who prepared the blood products were aware of the treatment assignments" (Page 1593).
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Loss after transfusion: 9.8% (51/521)
Loss after transfusion LR group: 10.8 (28/259)
Loss after transfusion Control group: 8.8% (23/262)
Imbalance between comparison groups: 2%
Selective reporting (reporting bias) Low risk Comment: The study protocol is available and all of the study's pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way.
Other bias Low risk Comment: The study appears to be free of other sources of bias.