Gallus 1973.
Methods | RCT | |
Participants | Patients (n = 350) over 40 years old admitted for elective surgery, or for emergency surgery after fracture of the femoral neck and medical patients suspected of having myocardial infarction. Mean age and gender were not reported separately for thoracic surgery patients, which represented less than 3% of the study population | |
Interventions | ‐ UFH 5000 IU sc 2 hours before surgery and then tid starting 8 to 10 hours after the preoperative dose. Treatment was continued until the participant was fully mobile ‐ Control: no UFH |
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Outcomes | DVT and bleeding. DVT was objectively verified by 125I‐fibrinogen scanning performed before surgery, within 4 hours of the end of surgery, and then daily until fully mobile or discharge. Venography was performed if the 125I‐fibrinogen scanning suggested the presence of thrombosis of the popliteal or femoral veins | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation not reported: "...were randomized separately" |
Allocation concealment (selection bias) | Unclear risk | Numbered, sealed envelopes. It remained unclear whether envelopes were opaque |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Surgeons were unaware of study treatment. Participants were not blinded and it is not reported if the other study personnel were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported if outcome assessment was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included were considered in the analysis |
Selective reporting (reporting bias) | Low risk | Study not registered. No published protocol. All outcomes mentioned in the methods section were addressed in the results section |
Other bias | Unclear risk | Participant characteristics are not reported. Unclear if participants were consecutively included |