Diedrich 2005.
| Methods | Parallel RCT (enrolled September 1996 to September 2001). Single centre. Sweden | |
| Participants |
Inclusion criteria: People undergoing an allogeneic haematopoietic stem cell transplant. All ages. Exclusion criteria: People with a known bleeding disorder or coagulopathy N = 166 (all included in analysis) Arm 1 N = 79 (acute leukaemia N = 47; chronic leukaemia N = 20; non‐malignant haematological disorder N = 4; other malignancy N = 8) Arm 2 N = 87 (acute leukaemia N = 36; chronic leukaemia N = 24; non‐malignant haematological disorder N = 11; other malignancy N = 16) |
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| Interventions | Comparison between prophylactic platelets with different transfusion triggers Arm 1 (Low transfusion trigger): If platelet count < 10 x 109/L Arm 2 (High transfusion trigger): If platelet count < 30 x 109/L In both arms prior to an operation or a biopsy, a platelet count > 50 x 109/L was aimed for. Platelet dose (mean ± SD):
Platelet type: pooled random‐donor platelets (buffy coat) 85% of platelet transfusions given; apheresis 15% of platelet transfusions given. All were ABO matched, irradiated, and leucodepleted |
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| Outcomes |
Primary outcome: Number of platelet transfusions Secondary outcomes:
Average number of days participants on study Not reported |
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| Bleeding scale | WHO Grade 1: petechiae Grade 2: mild blood loss Grade 3 ‐ 4: gross or debilitating blood loss Definition of significant bleeding: WHO Grade 2 ‐ 4 Definition of life‐threatening bleeding: Not stated |
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| Bleeding assessment | Daily bleeding assessment by nursing staff if inpatient, twice weekly bleeding assessment by nursing staff if outpatient | |
| Red cell transfusion policy | RBCs were transfused when haemoglobin decreased below 80 g/L | |
| Notes |
Participants randomised: documentation for study started 7 days prior to transplant Follow‐up: until 30 days post‐stem cell transplant Stopping rules: not reported Source(s) of funding: Supported by grants from: The Swedish Cancer Society (0070‐B99‐13XAC); The Children’s Cancer Foundation (2000/067, 02/074); The Swedish Medical Research Council (K2000‐06X‐05971‐20A); The Swedish Foundation for Medical Research; The Swedish Society of Medicine (2000‐02‐0553, 2001‐1299); The Cancer Society in Stockholm; The Tobias Foundation Conflicts‐of‐interest statement: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants were randomised after stratification, method of randomisation not stated |
| Allocation concealment (selection bias) | Unclear risk | Participants were randomised after stratification, method of allocation concealment not stated |
| Blinding of participants and personnel (performance bias) Participant | Unclear risk | It was unclear whether participants were blinded to the intervention, this was not reported in the published study |
| Blinding of participants and personnel (performance bias) Physician/Medical Staff | High risk | All platelet units were ordered by a nurse in charge of and responsible for the participant. The nurse was not blinded to the treatment arm for practical reasons |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Nurses from the ward, blinded to treatment arm, performed daily (inpatients) or twice weekly (outpatients) assessment and reported this. All platelet units were ordered by a different nurse in charge of and responsible for the participant. He or she was not blinded to the treatment arm for practical reasons. A special research nurse collected all data for the study |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to make an assessment |
| Selective reporting (reporting bias) | Unclear risk | No protocol available to assess whether all prespecified outcomes have been reported |
| Other bias | Low risk | The study appears to be free of other sources of bias |
| Protocol Deviation balanced? | Unclear risk | In participants with WHO Grade 2 ‐ 4 bleeding, violations of the protocol occurred in 4/14 participants in Arm 1 and 3/13 participants in Arm 2. The number of transfusions in which a protocol deviation occurred was not reported. Whether there were any protocol deviations in those participants that did not bleed was not reported |