Fischer 2011.
| Study characteristics | ||
| Methods | Study design: randomised trial Follow‐up: not reported |
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| Participants | Setting: European multicentre trial (10 centres) Number randomised: 121 (2 participants excluded postrandomisation) |
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| Interventions | Intervention: TachoSil (n = 60)
Control: argon beam coagulator (ABC: n = 59)
Co‐interventions: escape treatment was applied if haemostasis was not obtained within 10 minutes after the application of study treatment. No specific escape treatment was defined, but was chosen according to local protocols |
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| Outcomes | Primary outcome: time to haemostasis Secondary outcomes
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| Notes | 2 participants were excluded postrandomisation due to incorrect randomisation. 6 participants discontinued the study due to adverse events (2 in TachoSil group, 4 in ABC group). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Centralised telephone randomisation system. |
| Allocation concealment (selection bias) | Low risk | Centralised telephone randomisation system. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Assessors not blinded to allocation. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants and personnel not blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No follow‐up protocol specified. |
| Selective reporting (reporting bias) | Low risk | All relevant outcomes reported. |
| Other bias | Low risk | No other bias identified. |