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. 2023 Jan 26;2023(1):CD012144. doi: 10.1002/14651858.CD012144.pub3

Orken 2009.

Study characteristics
Methods Design: parallel group RCT
Setting: inpatient admissions to Sisli Etfal Education and Research Hospital, Department of Neurology in Turkey
Dates: January 2006 ‐ March 2008
Participants Sample size: 75 participants
Diagnosis: ICH
Inclusion criteria
  • Primary ICH > 48 hours after admission


Exclusion criteria
  • Early death before heparin treatment

  • death before 7th day investigations (see below)

  • secondary ICH due to aneurysm, arteriovenous malformations, trauma and tumours

  • excessive anticoagulation (INR > 2.0)

  •  contraindication to contrast agents


Age (years, mean (SD)): 68 ± 11 (intervention) 66 ± 10 (comparator)
Sex: 56% female (intervention), 22% female (comparator)
Interventions Intervention: subcutaneous LMWH (enoxaparin sodium 40mg/d) (39 participants)
Comparator: long compression stockings (36 participants)
Outcomes Primary outcome: not described
Secondary outcomes: not described
Outcomes
  • Haematoma enlargement (increase in ICH volume of > 33% or 12.5 mL) at 72 hours, 7 days and 21 days

  • Systemic bleeding complications

  • DVT or PE based on CTPA and bilateral venous Doppler at 7 days


Duration of follow‐up: 21 days
Notes Declarations of interest: not described
Sources of funding: not described
Other: it is not clear whether 4 patients who were excluded because of "death before 7th day investigations" were excluded before or after randomisation
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Randomisation was said to be done, "after the first 48 hours according to the order of hospital admission dates" which seems to be predictable and at high risk of bias
Allocation concealment (selection bias) High risk Randomisation was said to be done, "after the first 48 hours according to the order of hospital admission dates" which seems to be predictable and at high risk of bias
Blinding of participants and personnel (performance bias)
All outcomes High risk The intervention and comparator could not be blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "All radiologic material was prospectively evaluated by 2 radiologists ... who were blinded to the clinical findings and cranial CTs of the patients"
The methods did not explicitly state that the radiologists were also blinded to treatment allocation
Incomplete outcome data (attrition bias)
All outcomes Low risk Outcome data were complete
Selective reporting (reporting bias) Low risk All outcomes planned in the Methods section were reported in full in the Results section. Additionally, most expected outcomes of interest were reported in this study