Zufferey 2010.
Methods | Double blinded randomised trial | |
Participants | Population: 110 patients with isolated hip fracture Setting: France Date the study was conducted: 2005‐2006 |
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Interventions | Intervention: tranexamic acid 15 mg kg‐1 given at skin incision and 3 h later Control: saline at the same dose |
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Outcomes | Primary outcome: transfusion; secondary outcomes: bacterial infection, blood loss, deep venous thrombosis, pulmonary embolism, stroke, acute coronary syndrome and death. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: Computer generated randomisation |
Allocation concealment (selection bias) | Low risk | Quote: Central allocation by a telephone system |
Blinding of outcome assessment (detection bias) Mortality | Low risk | Quote: Masking was ensured by the administration of apparently identical saline drips. Patient caregivers, investigators collecting the data, safety monitoring board, and members of the adjudication committee remained unaware of study‐groups assignments |
Blinding of outcome assessment (detection bias) Transfusion | Low risk | Quote: Masking was ensured by the administration of apparently identical saline drips. Patient caregivers, investigators collecting the data, safety monitoring board, and members of the adjudication committee remained unaware of study‐groups assignments |
Blinding of outcome assessment (detection bias) Complications | Low risk | Quote: Masking was ensured by the administration of apparently identical saline drips. Patient caregivers, investigators collecting the data, safety monitoring board, and members of the adjudication committee remained unaware of study‐groups assignments |
Incomplete outcome data (attrition bias) Mortality | Low risk | Quote: All the analyses were based on the intention‐to‐treat principle and no reported loss to follow‐up |
Incomplete outcome data (attrition bias) Transfusion | Low risk | Quote: All the analyses were based on the intention‐to‐treat principle and no reported loss to follow‐up |
Incomplete outcome data (attrition bias) Complication | Low risk | Quote: All the analyses were based on the intention‐to‐treat principle and no reported loss to follow‐up |
Selective reporting (reporting bias) | Low risk | Quote: All the analyses were conducted according to a pre specified statistical analysis plan |
Other bias | Unclear risk | ‐ |