Characteristics of included studies [ordered by study ID]
Auer 1979
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| Methods | Probable RCT: "Twenty patients were included in a double-blind study; nine patients were treated with Trasylol. Eleven received a placebo drug." However, five additional patients were added to the study and received aprotinin treatment. These patients were not separated out in the analysis. |
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| | Participants | Patients with severe head injury who had remained comatose for seven days. Most of them had clinical brain stem signs. |
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| | Interventions | Aprotinin group: 500,000 IE initially thereafter 200,000 IV every four hours. |
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| | Outcomes | Death.
Range of biochemical end points. |
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| | Notes | Because it was not possible to separate the 5 non-randomised patients from the 20 probably randomised patients, this study provides no useable outcome data. |
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| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Allocation concealment? | Unclear | B - Unclear |
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McMichan 1982
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| Methods | RCT: Aprotinin and placebo were supplied in identical coded ampoules. Ampoules were in boxes of 50 with a code number assigned to each box. These numbers were randomised in groups of 20 and each batch was assigned in numerical order. The codes were not broken until the end of the study.
Patients excluded after randomisation were those who died within the first 24 hours or refused continuing investigation. |
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| | Participants | Patients with a combination of hypovolaemic shock and major fractures of the lower limb and or pelvis. Patients seen 12 or more hours after injury and those with major head or chest injuries were excluded. |
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| | Interventions | Aprotinin group: 500,000 Kallikrein Inhibitor Units (KIU) IV statim followed by 300,000 KIU at 6-hour intervals for 96 hours. |
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| | Outcomes | Death.
Mean blood transfusion.
Respiratory function. |
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| | Notes | 77 patients were randomised but there were 7 post-randomisation exclusions. Among the 7 excluded patients, there were 3 deaths within the frist 24 hours of injury. One patient was transferred to another hospital because of quadriplegia and died later, and three patients refused investigation.
It was noted in the results that the data on transfusion requirement was found to have a non-normal distrubution. Nevertheless, the mean and standard deviation were presented. |
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| | Risk of bias |
| | Item | Authors' judgement | Description |
| | Allocation concealment? | Yes | A - Adequate |
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Characteristics of excluded studies [ordered by study ID]
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| Study | Reason for exclusion |
|---|
| | Gierhake 1971 | Types of patients: general surgery patients not trauma. |
| | Husted 2003 | Types of patients: orthopaedic patients not trauma. |
| | Klobow 1977a | Types of interventions: trasylol compared with heparin. |
| | Klobow 1977b | Types of interventions: trasylol compared with heparin. |
| | Kuiian 1999 | Types of studies: After Dr Vasiliy Vlassov, Director of the Russian Branch of the Nordic Cochrane Centre kindly translated the methods section it was clear that this study was not randomised. |
| | Loew 1970 | Types of studies: alternation used not random allocation. |
| | Nissen 1989 | Types of studies: review article not randomised controlled trial. |
| | Schneider 1976 | Types of studies: randomisation in this trial was by allocating patients to the treatment group according to the day of admission. However, this procedure was subverted for large numbers (813) of patients in which case the study cannot be considered to be a randomised controlled trial. |
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Comparison 1. Aprotinin versus none
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| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Death | 1 | 70 | Odds Ratio (M-H, Fixed, 95% CI) | 0.13 [0.01, 2.63] |
| | 2 Proportion undergoing surgical intervention | 1 | 70 | Odds Ratio (M-H, Fixed, 95% CI) | 1.5 [0.43, 5.28] |
| | 3 Proportion undergoing re-operation | 0 | 0 | Odds Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | 4 Proportion receiving blood transfusion | 0 | 0 | Odds Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | 5 Volume of blood transfused | 1 | 70 | Mean Difference (IV, Fixed, 95% CI) | -0.40 [-0.91, 0.11] |
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