Bowley 2006.
Methods | Randomised controlled trial | |
Participants |
Participants: 44 participants (21 allocated to intervention group; 23 to control) Age: range 20 to 54 years (median 30 years) Demographics: 40 of 44 participants were male. Other demographics as well as injury patterns and severity were apparently equivalent at baseline between the two groups Unit of allocation: individual Number randomised: 44 Number completing: 15 survived; 29 died Setting: Johannesburg Hospital Trauma Unit, Dept of Surgery, University of the Witwatersrand, South Africa. Study recruited within the first seven months of 2002 Inclusion criteria: Participants were "assessed on arrival in the Emergency Room by a single investigator and enrolled in the study if they had penetrating torso injury requiring a laparotomy and had exhibited hypotension (< 90 mmHg) either pre‐hospital or on arrival and in whom there was considered to be significant blood loss" (p. 1075) Exclusion criteria: Participants aged < 18 years; participants with injuries > 6 hours old. |
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Interventions |
Intervention (n = 21): the intervention group underwent cell salvage using a Cell Saver 4 machine (Haemonetics, Braintree, MA, USA) with transfusion of both autologous and allogeneic blood as required Control (n = 23): allogeneic blood transfusion at the discretion of the attending medical staff |
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Outcomes |
Primary Exposure to allogeneic blood up to the first 24 hours postinjury Secondary Mortality (all cause and cause‐specific (e.g. multiorgan failure or exsanguination) Postoperative sepsis Costs |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was by computer‐generated random number tables |
Allocation concealment (selection bias) | Low risk | Allocation was concealed by means of envelopes which contained dedicated data collection sheets |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It is not feasible to blind this intervention to personnel |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Insufficient information was available in the published paper to determine this. Contact with the primary investigator indicates no attempts at blinding outcome assessors to outcomes e.g. postoperative sepsis |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No data were missing from this study |
Selective reporting (reporting bias) | Unclear risk | Contact with trial investigator has established that no trial protocol exists (Bowley 2006) |
Other bias | Low risk | No other sources identified |