Ninet 1991.

Methods	Study design: randomised controlled trial. Method of randomisation: stratified to medical or surgical context in which VTE occurred. Concealment of allocation: not blinded for treatment allocation, blinded for outcome assessment. Exclusions post‐randomisation: none. Lost to follow‐up: 18 participants for assessment of change in thrombus size on venogram. No participants lost to follow‐up for assessment of bleeding events.
Participants	Country: France (17 centres). Setting: hospital. No.: 166 participants undergoing medical or surgical procedures. Age: estimated overall mean age 63 years. Sex: not stated. Inclusion criteria: recent (< 5 days) proximal DVT. Exclusion criteria: thrombosis affecting inferior vena cava; contraindication to heparin; platelets < 100,000/mm³; blood disease; surgery < 3 days previously; contraindication for isotopic/venographic investigation; pulmonary vascular obstruction 30% or more (lung scan); 24 hours or more heparin or oral anticoagulant therapy; recent history (< 2 years) of cerebrovascular accident or thromboembolic episode; pregnancy.
Interventions	Treatment: LMWH: fraxiparine body weight‐adjusted fixed dose (± 90 anti‐factor Xa IU/kg, s.c., twice daily) Control: UFH: dose‐adjusted APTT × 1.5 to 2.0, continuous i.v. infusion started with 20 IU/kg/hour. No bolus injection. Treatment duration: 10 days. Oral anticoagulation: not defined for either group.
Outcomes	Primary: change in thrombus size (Marder's score); recurrent venous thromboembolism (VTE) during initial treatment. Secondary: haemorrhagic episodes during initial treatment; mortality at the end of follow‐up.
Notes	Repeated venography on day 0 and day 10. Follow‐up was not conducted prospectively at the study centre. 18 (8 versus 10) participants lost to follow‐up. Follow‐up by assessment on information noted and communicated by general practitioners.
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	Low risk	Not blinded for treatment allocation. Comment: given the clinical outcomes of the study, review authors judged that the non‐blinding of the participants and staff was unlikely to have affected the outcomes.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Venography was evaluated blind by 2 independent radiologists (coded films).
Incomplete outcome data (attrition bias) All outcomes	High risk	Recurrences were excluded.
Selective reporting (reporting bias)	Low risk	Published report includes all expected outcomes.
Other bias	Low risk	There are more baseline risk factors in the UFH group compared to the CY 216 group. However, this difference was not statistically significant.