Dahl 1997.
Methods |
Study design: Randomised, prospective, double‐blind, placebo‐controlled trial Country: Norway Setting: Multicentre, hospital and home, January 1993 ‐ June 1994 Intention‐to‐treat: Yes, after withdrawals removed. For the purposes of our meta‐analyses we used the reported ITT population |
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Participants |
Number randomised: Total n = 265 (extended LMWH n = 134; placebo n = 131) Exclusions post randomisation: Total n = 38 (extended LMWH n = 17; placebo n = 21) withdrawn for reasons other than DVT or PE (21/38 due to adverse events: 10 extended LMWH and 11 placebo) Losses to follow up: No losses to follow‐up all participants received treatment until the day of final visit Age mean years: Extended LMWH 70.98, placebo 71.4 Sex %F: Extended LMWH 68.5%; placebo 73.6% Inclusion criteria: 18 years or older; admitted to hospital for elective primary or secondary hip replacement; obtained written consent form Exclusion criteria: Known renal or liver insufficiency; cerebral bleeding less than three months before surgery or known haemorrhagic diathesis; eye or ear surgery within one month before surgery; severe hypertension; septic endocarditis; threatened arterial circulation in the leg; body weight less than 40 kg; anticoagulant therapy less than one week before surgery; known hypersensitivity to heparin, low‐molecular‐weight heparin, dextran or contrast media; pregnancy or breastfeeding; inability to comply with study protocol; previous surgery within study |
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Interventions |
Treatment: Dalteparin 5000 IU, injections once daily for four weeks Control: Initial treatment with dalteparin 5000 IU followed by placebo (sodium chloride) injections, once daily Duration: 35 days (7 days initial treatment + 28 days continued treatment) |
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Outcomes |
Primary: Verified VTE on days 7 and 35 Secondary: Haematological assessment; safety: reoperation due to bleeding, wound haematoma and local haematoma at injection site |
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Notes |
Funding: Not reported Method of VTE evaluation/confirmation: DVT verified by bilateral venography and PE verified by perfusion ventilation or chest X‐ray |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information given to determine adequate randomisation |
Allocation concealment (selection bias) | Unclear risk | Insufficient information given to determine adequate allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as double‐blinded and gave placebo subcutaneous injections |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Venograms, X‐rays and V‐Q scans evaluated after the study by a blinded specialist |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for, ITT and PP analysis |
Selective reporting (reporting bias) | High risk | VAS patient acceptability reported but not reported as pre‐planned, as was pain at injection site and serious adverse events, bleeding not reported as outcomes |
Other bias | Low risk | No evidence of other bias |