Meyer 1995.
Methods | Study design: randomised, multicentre pilot study. Method of randomisation: not stated. Concealment of allocation: sealed envelopes, not blinded for treatment allocation, blinded for outcome assessment. Exclusions post‐randomisation: none. Lost to follow‐up: none. |
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Participants | Country: France. Setting: hospital. No.: 60 participants: 29 LMWH, 31 UF heparin. Age: mean 60 (range 26 to 84) years LMWH, mean 61 (20 to 88) years UF heparin. Sex: LMWH 9 M/20 F, UF heparin 17 M/14 F Inclusion criteria: men and women > 18 years, weighing 45 to 90 kg and with onset of symptoms suggestive of acute PE within the 5 preceding days. Exclusion criteria: known pregnancy or breastfeeding, major surgical procedure or organ biopsy within the last 5 days, ischaemic cerebrovascular accident within the past 30 days or cerebral haemorrhage within the last 3 months, known haemorrhagic diathesis, active peptic ulcer, pre‐existing significant cardiorespiratory disease, known proliferative diabetic retinopathy, known allergy to heparin or contrast media, platelet count < 100 10⁹/L, chronic renal failure, chronic liver disease, treatment with UFH or LMWH at full dosage for more than 24 hours before randomisation, planned hospital stay < 10 days, oral anticoagulant therapy within 5 days before randomisation and any clinical condition which in the opinion of the physician in charge would not allow safe fulfilment of the protocol. |
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Interventions | Treatment: LMWH: fragmin at a fixed dose of 120 anti‐Xa IU/kg subcutaneously twice daily and without any laboratory adjustment. Control: UFH as a continuous intravenous infusion at an initial dosage of 500 IU/kg/24 hours and adjusted daily to maintain APTT between 2 to 3 times the control value. Treatment duration: 10 days Oral anticoagulation: acenocoumarol started on day 7 and continued for at least 3 months |
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Outcomes | Primary: incidence of PE recurrence within the first 10 days of treatment Secondary: pulmonary scintigraphic vascular obstruction score (PVOS), major bleeding |
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Notes | Follow‐up: 3 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Treatment was randomly allocated". Comment: insufficient information to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Quote: "Treatment was randomly allocated using sealed envelopes". Comment: although the use of assignment envelopes is described, it remains unclear whether envelopes were sequentially numbered and opaque. |
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 | Quote: "Open study. All angiograms were reviewed and scored blindly by 3 independent readers unaware of the treatment allocation and clinical events that occurred during the trial. Perfusion lung scans were reviewed and scored blindly by 2 independent readers according to the same procedure". Comment: review authors judged that the non‐blinding of the participants and staff was unlikely to have affected the outcomes. Furthermore, the blinding of outcome assessment was ensured. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All data accounted for. |
Selective reporting (reporting bias) | Low risk | Study reports data on all pre‐specified outcomes. |
Other bias | Low risk | Study appears to be free from other sources of bias. |