Pince 1981.
| Study characteristics | ||
| Methods | C: sealed envelopes (? opaque and sequentially numbered) Non‐blinded Ex during trial: Rx 0, control 4 participants (2 with ICH) Losses to FU: none | |
| Participants | France 80 participants Age range: 30 to 92 years 62% male No CT, 100% LP before entry Ischaemic stroke affecting the leg Less than 7 days since stroke onset (89% < 48 hours) | |
| Interventions | Rx: heparin 5000 IU subcutaneous 8‐hourly Control: no treatment Duration: 10 days | |
| Outcomes | Death but not cause of death DVT (systematic I‐125 scan) PE Major extracranial haemorrhage | |
| Notes | Ex: bleeding risk FU: 10 days | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "l’attribution du type de traitement est faite d’après la randomisation sous enveloppe …" Translation: "attribution of treatment type is done after randomisation with sealed envelope …" |
| Allocation concealment (selection bias) | Low risk | Treatment and placebo groups have the same conditioning and the same posology |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No information given |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "placebo et antiagrégants sont pour nous indiscernables ..." Translation: "placebo and antiaggregant are indistinguishable for us [the personnel] …" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given on blinded assessment of outcomes |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 9/120 patients excluded |
| Selective reporting (reporting bias) | Low risk | Mentioned outcomes of frequency of phlebitis, side effects of treatments, and clinical evolution in function of treatment reported |