Aronstam 1977.
Study characteristics | ||
Methods | Single‐centre RCT. Cross‐over trial. Trial conducted over 2 school terms. Note: there are 3 school terms per annum in the UK. |
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Participants | Country: England.
Participants: males with haemophilia A (factor VIII < 1%).
Age range: 13 ‐ 17 years.
Number enrolled: 4 All participants completed the trial. Those boys who had been on the first double‐blind controlled trial (Aronstam 1976) and were still available for a further 2 terms were selected. There were 4 such boys, patients 1, 3, 8, and 9 of that trial. The boys selected had each had at least one full school term off prophylaxis before entering the second trial. |
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Interventions | Cryoprecipitate (prepared by Wessex Regional Transfusion Centre) or Kryobulin (prepared by Serological Products, UK).
Type of prophylaxis: 2 prophylaxis arms; Arm A: raise factor VIII to 15% twice weekly. Arm B: raise factor VIII to 30% twice weekly. Follow‐up duration: 2 school terms |
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Outcomes | Bleeding events or frequency. | |
Notes | Source of funding: Sir William Coxon Trust and the Lord Mayor Treloar Trust. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | While authors indicated that random sequence generation was used to allocate participants to groups, no details were given. |
Allocation concealment (selection bias) | Unclear risk | No details on allocation concealment were given. |
Blinding (performance bias and detection bias) Clinical Joint Function | Unclear risk | Not assessed. |
Blinding (performance bias and detection bias) Bleeding | Low risk | Participants and personnel were unaware of allocation. |
Blinding (performance bias and detection bias) Radiologic Joint Score | Unclear risk | Not assessed. |
Blinding of outcome assessment (detection bias) Bleeding | Low risk | Outcome assessors were blinded to allocation. |
Blinding of outcome assessment (detection bias) Clinical Joint Function | Unclear risk | Not assessed. |
Blinding of outcome assessment (detection bias) Radiologic Joint Score | Unclear risk | Not assessed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data are present for all participants. |
Selective reporting (reporting bias) | Low risk | While the trial protocol was not available, all expected outcomes were reported for all participants. |
Other bias | Unclear risk | Washout period between arms is unclear. |