Deep Venous Thrombosis, Hemorrhagic Stroke, Venous Thromboembolism
Conditions
Keywords
hemorrhagic stroke, venous thromboembolism, prevention
Brief summary
Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism. Intermittent pneumatic compression combined with elastic stockings have been shown to be superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism in patients with ICH because the use of anticoagulants may cause an enlargement of the hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization) will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke onset.
Interventions
DRUGEnoxaparin
enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke
OTHERGraduated compression stockings and/or intermittent pneumatic compression and/or early mobilization
placebo standard therapy
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Intracranial spontaneous hemorrhage on brain CT scan * Intracranial hemorrhage during treatment with oral anticoagulants * Bedridden patients (item 6 of NIHSS: motor leg points 3 or 4 or severe ataxia for cerebellar hemorrhage).
Exclusion criteria
* cerebral hemorrhage due to intracranial vascular malformation * rebleeding on CT scan after 72 hours from stroke (before randomization)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism | 10 days | Symptomatic venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) and asymptomatic deep venous thrombosis on ultrasound examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleedings | 90 days | symptomatic and asymptomatic intra and extracranial bleedings |
| Mortality | 90 days | mortality of any cause |
| Disability | 90 days | modified Rankin Scale (mRS) equal to and greater than 3. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
Countries
Italy
Participant flow
Pre-assignment details
No wash-out, nor run-in events.
Participants by arm
| Arm | Count |
|---|---|
| Low Weight Molecular Heparin enoxaparin 0.4 ml subcutaneous per day
Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke | 38 |
| Standard Therapy Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization
Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy | 35 |
| Total | 73 |
Baseline characteristics
| Characteristic | Low Weight Molecular Heparin | Standard Therapy | Total |
|---|---|---|---|
| Age, Continuous | 70.4 years STANDARD_DEVIATION 13.7 | 71.5 years STANDARD_DEVIATION 11.6 | 70.9 years STANDARD_DEVIATION 12.6 |
| Obesity | 3 Participants | 3 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Male | 22 Participants | 18 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 38 | 6 / 35 |
| other Total, other adverse events | 0 / 38 | 0 / 35 |
| serious Total, serious adverse events | 1 / 38 | 3 / 35 |
Outcome results
Primary
Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism
Symptomatic venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) and asymptomatic deep venous thrombosis on ultrasound examination
Time frame: 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Weight Molecular Heparin | Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism | 6 Participants |
| Standard Therapy | Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism | 7 Participants |
Secondary
Bleedings
symptomatic and asymptomatic intra and extracranial bleedings
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Weight Molecular Heparin | Bleedings | 1 Participants |
| Standard Therapy | Bleedings | 3 Participants |
Secondary
Disability
modified Rankin Scale (mRS) equal to and greater than 3. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Weight Molecular Heparin | Disability | 27 Participants |
| Standard Therapy | Disability | 30 Participants |
Secondary
Mortality
mortality of any cause
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Weight Molecular Heparin | Mortality | 7 Participants |
| Standard Therapy | Mortality | 6 Participants |