Harenberg 2000a.

Methods	Study design: randomised controlled trial. Method of randomisation: not stated. Concealment of allocation: blinded for outcome assessment. Exclusions post‐randomisation: not stated. Lost to follow‐up: not stated.
Participants	Country: Austria, Germany, Switzerland, Czech Republic. Setting: hospital. No.: 541 were eligible of which 3 withdrew informed consent; therefore 538 participants were assigned. Age: 30 years and older. Sex: Males and females (breakdown not supplied). Inclusion criteria: acute symptomatic proximal DVT (thrombosis of the popliteal vein or proximal) documented by ascending venography. Exclusion criteria: indication for surgical or fibrinolytic treatment of DVT; duration of symptoms for more than 3 weeks; ongoing oral anticoagulation; renal failure; severe hypertension (> 200 mmHg systolic and > 105 mmHg diastolic while on antihypertensive treatment); severe hepatic failure; currently active bleeding or disorders contraindicating anticoagulant therapy; contraindication to oral anticoagulants; pregnancy; known intolerance to heparins; intolerance to contrast media; any operation within the past 8 days; acute severe PE; platelet count < 100,000/µL; treatment with heparin > 24 hours before inclusion; treatment with platelet‐inhibiting drugs (100 mg or more acetylsalicylic acid daily allowed).
Interventions	Treatment: LMWH: fixed dose 8000 anti‐factor Xa IU (Certoparin) s.c., twice daily Control: UFH: adjusted to APTT 2 to 3 × the reference value. Treatment duration: 7 to 15 days. Oral anticoagulation: at least 6 months.
Outcomes	Primary: change in thrombus size (Marder's score), recurrent VTE, major bleeding and death during treatment and after 6 months' test follow‐up.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information.
Allocation concealment (selection bias)	Unclear risk	Insufficient information.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Data on all potential outcome events were evaluated by an independent committee, which was unaware of the treatment assignment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing outcome data balanced in numbers across intervention groups.
Selective reporting (reporting bias)	Low risk	Published report includes all expected outcomes.
Other bias	High risk	The study was sponsored by Novartis Pharmacological GmbH, Nuremberg, Germany.