| Study characteristics |
| Methods |
C: sealed, opaque but not sequentially numbered envelopes
Non‐blinded
Ex during trial: none
Losses to FU: none |
| Participants |
USA
131 participants
Mean age: 71 years
50% male
100% CT before entry
Ischaemic stroke with severe leg weakness
Less than 14 days since stroke onset |
| Interventions |
Rx: heparin 5000 IU subcutaneous 8‐hourly, with dose adjustment to maintain PT 30 to 40 seconds
Control: no treatment
Duration: 28 days |
| Outcomes |
Death plus cause of death
DVT (systematic B mode and Doppler ultrasound)
PE
Major extracranial haemorrhage |
| Notes |
Ex: bleeding risk, active cancer
FU: 28 days |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Sealed envelope used for randomisation |
| Allocation concealment (selection bias) |
Low risk |
Patients randomly assigned to groups in 3 clusters of 22; i.e. 22 As, 22 Bs, and 22 Cs were placed in a sealed envelope |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Blinded design of the study not reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding of treatment allocation to participants/personnel not reported |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Blinding of treatment allocation to outcome assessor not described |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Only 175/259 completed the study; no detailed reasons provided why patients lost to follow‐up |
| Selective reporting (reporting bias) |
Low risk |
Outcomes mentioned in methods reported |
