Hedstrom 1996.
| Methods | Design: Randomised controlled trial. Setting: Sweden. | |
| Participants | N = 80 patients undergoing total hip replacement for primary coxarthrosis (78 patients included in the analysis).
Inclusion/Exclusion criteria: Patients with hepatitis, severe coronary artery disease or heart failure, haematologic diseases, Hb concentration < 110 g/L or body weight < 50 kg were not eligible. |
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| Interventions |
Timing of autologous blood collection/retransfusion: one 4 weeks before surgery and the other 2 weeks before the scheduled operation. The blood was stored at +4.0 degrees celsius for not more than 6 weeks and was handled according to existing routines and regulations for allogeneic blood. All autologous blood, as well as the allogeneic blood, was retransfused as packed red blood cells (leukocyte depleted blood) if needed. Volume of autologous blood collected/retransfused: autologous group donated 2 units of blood. Iron supplementation: All patients received iron supplementation consisting of 100 mg Fe2+ given orally 2 times a day after the first donation until the day of the operation. Use of transfusion threshold: Not reported. Length of surgery: Average of 107 and 97 minutes in PAD and control groups respectively. |
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| Outcomes | Outcomes reported: Number of patients exposed to allogeneic blood (n), allogeneic blood transfused (units), blood loss (mL), haemostatic parameters (bleeding times). | |
| Notes | Period of study: Not reported. Length of study: Not reported. A priori sample size: Not reported. Baseline comparability: Not reported. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | No information. |
| Allocation concealment? | Unclear risk | Patients were randomly allocated by the use of sealed envelopes. |
| Blinding? All outcomes | Unclear risk | No information. |
| Intention‐to‐treat analysis? | High risk | Data were not analysed on an intention‐to‐treat basis. |