ISRCTN55488814.
Methods | Participants aged 18 and over scheduled for hip or knee replacement at a single centre were randomised to one of two groups. The method of randomisation and allocation concealment is not described. The trial is described as double‐blind but does not state to whom this refers. |
Participants | A target of 130 participants aged 18 years and over scheduled for hip or knee replacement surgery at a single centre were randomised to one of two groups: Autotransfusion group Control group |
Interventions |
Autotransfusion group: the autotransfusion group will receive their own wound blood within 6 hours after the operation Control group: the control group will not receive their own wound blood within 6 hours after the operation. |
Outcomes | Outcomes reported: serum concentrations of Hb, activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen, thrombin‐antithrombin (TAT) assay. Prothrombin fragment (PF1+2) and D‐dimer levels measured at 12 hours pre‐operatively, 3 hours postoperatively, 1 and 4 hours after re‐infusion of autologous wound blood, 24 hours, 14 days, 6 weeks and 3 months postoperatively; the number of allogeneic blood transfusions registered; colour duplex sonography; number of postoperative transfusion reactions; number of secondary wound infections |
Notes |
Transfusion protocol: a transfusion protocol was used but details of this are not available. Prospective registration status: the study was registered retrospectively. Ethical approval: the study was approved by the Medical Ethical Board of the Maxima Medical Centre, Eindhoven on 15 April 2004 (ref: 0419). Language: study information on the ISRCTN registration page is available in English. Reason for awaiting classification status: study information is available from the ISRCTN registration page. Study results are not yet available despite the trial having been completed for more than 2 years. There is insufficient information to determine whether the study is eligible for inclusion. |