Lapidus 2007a.
Methods | Study design: randomized, controlled, double‐blind trial Method of randomization: by computer Concealment of allocation: not specifically reported Losses to follow‐up: 4 (withdrawal of consent treatment group 2, control group 2) and excluded from efficacy analysis |
|
Participants | Country: Sweden Number randomized: 105; treatment group 52; control group 53 Number reported, included in analysis 1 (all participants with negative color duplex sonography, and all participants with DVT verified by phlebography): 91; treatment group 47; control group 44 Number reported, included in analysis 2 (all participants with color duplex sonography for patients with multiple distal DVT or proximal DVT, and all participants with DVT verified by phlebography): 96; treatment group 49; control group 47 Age mean (SD): treatment group 37 years (8); control group 42 years (9) Sex (male/female): treatment group 41/11; control group 42/11 Inclusion criteria: age 18 to 75 years, admitted for an acute (0 to 72 hours) Achilles tendon rupture, accepted for surgery Exclusion criteria: inability or refusal to give informed consent, ongoing treatment with anticoagulant therapy, known allergy for contrast media, kidney disorder, recent thromboembolic event, recent surgery, known malignancy, current bleeding disorder, pregnancy, treatment with platelet inhibitors |
|
Interventions | Treatment group: LMWH dalteparin 5000 units sc once daily until removal of the plaster cast Control group: placebo |
|
Outcomes | Diagnosis of DVT by means of ultrasound and confirmation by venography | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization by computer, no further information provided. However, patients were not included when study personnel were off duty |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Study described as double‐blind. Each patient received a box containing 45 prefilled syringes with either Dalteparin or placebo. Syringes of both groups were identical. Blinding of personnel was not explicitly described. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "evaluation was carried out by an experienced independent radiologist blinded to the randomization and previous phlebographic findings" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 patients were lost to follow‐up, evenly divided between the two groups. |
Selective reporting (reporting bias) | Low risk | Outcome measures were reported, as well as any adverse event. |
Other bias | Low risk | No other bias was detected. |