Faivre 1988.
Methods | Study design: randomised controlled trial. Method of randomisation: not stated. Concealment of allocation: not blinded for treatment allocation, blinded for outcome assessment. Exclusion post‐randomisation: 1 in UFH group (thrombocytopenia). Lost to follow‐up: 9 participants had no second phlebography (3 CY 222, 6 UFH). |
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Participants | Country: France. Setting: hospital. No.: 68 participants. Age: mean 66 years. Sex: 39 males. Inclusion criteria: symptomatic DVT and/or symptomatic PE, or symptomatic PE confirmed by ventilation‐perfusion scan and a positive phlebogram. Exclusion criteria: > 2 weeks symptoms of DVT or PE with massive PE; extension of the thrombus into the inferior vena cava. |
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Interventions | Treatment: LMWH: CY 222 starting with a bolus injection i.v. 5000 U anti‐factor Xa IU and continued with body weight‐adjusted fixed dose: 155 IU/kg (750 U anti‐factor Xa IU/kg/24 hours), s.c., twice daily. Control: UFH: starting with a bolus injection i.v. 5000 IU of UFH and continued with 500 IU/kg/24 hours s.c., twice daily; dose‐adjusted APTT × 2.0 to 3.0. Treatment duration: 10 days. Oral anticoagulation: not defined for treatment or control groups. |
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Outcomes | Primary: change in thrombus size (Marder's score); recurrent DVT and PE. Secondary: major haemorrhage during the initial treatment. |
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Notes | Baseline characteristics: difference in presence of PE (66% of participants allocated to LMWH and 34% of participants allocated to UFH had a PE). Repeated venography; participants with thrombotic and bleeding events excluded from venographic evaluation. Unclear from publication whether valid criteria for diagnosis of recurrent VTE were used. No prospective follow‐up. | |
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 | Blinded for outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information. |
Other bias | Unclear risk | Insufficient information. ? baseline differences mentioned above? |