Kock 1995.
Methods | Study design: randomized, controlled, open trial Method of randomization: randomization list stratified for varicose veins and obesity Concealment of allocation: not reported Losses to follow‐up: 5 refused to take part, 32 excluded due to exclusion criteria, data not evaluated from 52: treatment group 21; control group 31 |
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Participants | Country: Germany Number randomized: 428; 5 refused to take part, 32 excluded due to exclusion criteria, data not evaluated from 52: treatment group 21; control group 31 (no final examination (12 treatment; 16 control), surgery performed before final examination (6 treatment, 12 control), changed groups (3 treatment, 3 control)) Number reported, included in analysis, presented in study publication: 339 (treatment group 176; control group 163) Age mean (range): treatment group 34.1 years (18 to 63); control group 33.5 years (18 to 64) Sex (male/female): treatment group 104/72; control group 104/59 Inclusion criteria: age 18 to 65, conservative treatment of injury with below‐knee cast or cylinder cast Exclusion criteria: previous DVT, pregnancy, clotting disorders or anticoagulation medication, bleeding, chronic venous insufficiency, contraindications for heparin prophylaxis, plaster cast after surgery |
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Interventions | Treatment group: LMWH 32 mg (certoparin; Mono‐Embolex NM) once daily Control group: no prophylaxis |
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Outcomes | At randomization and at plaster removal, compression ultrasound and duplex scanning were performed; suspected positive findings were confirmed by phlebography. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization with lists stratified for varicose veins and obesity |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open study format, in which no placebo was used. The treatment group received injections of LMWH, the control group received none. Blinding of personnel was not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data of 52 out of 428 randomized participants could not be evaluated, reasons provided |
Selective reporting (reporting bias) | Unclear risk | Primary and secondary outcomes were not described. Therefore, it was unclear whether all assessed outcomes were reported. |
Other bias | Low risk | No other bias was detected. |