Skip to main content
. 2017 Feb 9;2017(2):CD001100. doi: 10.1002/14651858.CD001100.pub4

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).
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.
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.
Outcomes Primary: change in thrombus size (Marder's score); recurrent DVT and PE.
Secondary: major haemorrhage during the initial treatment.
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?