| Study characteristics |
| Methods |
C: permuted blocks with randomly ordered sizes of 6, 6, and 4; randomisation lists pharmacy controlled
Doctor, patient, and assessor blinded
Ex during trial: none
Losses to FU: 25 participants (11 treatment, 14 control) |
| Participants |
USA
1281 participants
Mean age: 65 years
61% male
100% CT before entry
Ischaemic stroke > 1 hour and < 24 hours from symptom onset with estimated pre‐stroke Barthel Index ≥ 12 |
| Interventions |
Rx: danaparoid (heparinoid Org 10172) bolus followed by continuous infusion to maintain blood anti‐Xa levels of 0.6 to 0.8
Control: placebo
Duration: 7 days |
| Outcomes |
Functional outcome: Barthel Index < 85, NIHSS, Glasgow Outcome Scale
Recurrent stroke
ICH (symptomatic CT)
Extracranial haemorrhage |
| Notes |
Ex: age < 18 or > 85, women of childbearing potential, severe stroke (NIHSS score > 15), weight < 125 pounds
FU: 7 days and 3 months |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomised 1:1 to treatment with ORG 10172 or placebo using permuted blocks with randomly ordered sizes and balanced for every 16 consecutive patients |
| Allocation concealment (selection bias) |
Low risk |
Randomised using permuted blocks |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, placebo‐controlled trial |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blind design |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Double‐blind design |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
2/646 in treatment and 5/635 in control lost to follow‐up |
| Selective reporting (reporting bias) |
Low risk |
Outcomes mentioned in methods reported |
