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The trial has been terminated prematurely after the randomization of 73 patients due to a lack of funding.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low weight molecular heparin | Experimental | enoxaparin 0.4 ml subcutaneous per day |
|
| standard therapy | Placebo Comparator | Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bleedings | symptomatic and asymptomatic intra and extracranial bleedings | 90 days |
| Mortality | mortality of any cause | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stroke Unit | Perugia | 06126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21324058 | Background | Paciaroni M, Agnelli G, Venti M, Alberti A, Acciarresi M, Caso V. Efficacy and safety of anticoagulants in the prevention of venous thromboembolism in patients with acute cerebral hemorrhage: a meta-analysis of controlled studies. J Thromb Haemost. 2011 May;9(5):893-8. doi: 10.1111/j.1538-7836.2011.04241.x. | |
| 36700520 | Derived |
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No wash-out, nor run-in events.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Standard Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 10 days |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| extracranial bleeding | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maurizio Paciaroni | Stroke Unit and Division of Internal and Cardiovascular Medicine University of Perugia, Santa Maria della Misericordia Hospital | +390755786424 | maurizio.paciaroni@unipg.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 1, 2011 | Sep 9, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000083302 | Hemorrhagic Stroke |
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization | Other | placebo standard therapy |
|
| Disability | modified Rankin Scale (mRS) equal to and greater than 3. 0 - No symptoms.
| 90 days |
| Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3. |
| 33190135 | Derived | Paciaroni M, Agnelli G, Alberti A, Becattini C, Guercini F, Martini G, Tassi R, Marotta G, Venti M, Acciarresi M, Mosconi MG, Marcheselli S, Fratticci L, D'Amore C, Ageno W, Versino M, De Lodovici ML, Carimati F, Pezzini A, Padovani A, Corea F, Scoditti U, Denti L, Tassinari T, Silvestrelli G, Ciccone A, Caso V. PREvention of VENous Thromboembolism in Hemorrhagic Stroke Patients - PREVENTIHS Study: A Randomized Controlled Trial and a Systematic Review and Meta-Analysis. Eur Neurol. 2020;83(6):566-575. doi: 10.1159/000511574. Epub 2020 Nov 13. |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Obesity | Count of Participants | Participants |
|
|
|
| Secondary | Bleedings | symptomatic and asymptomatic intra and extracranial bleedings | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Mortality | mortality of any cause | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Disability | modified Rankin Scale (mRS) equal to and greater than 3. 0 - No symptoms.
| Posted | Count of Participants | Participants | 90 days |
|
|
|
| 7 |
| 38 |
| 1 |
| 38 |
| 0 |
| 38 |
| EG001 | 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 | 6 | 35 | 3 | 35 | 0 | 35 |
| Intracranial bleedings | Nervous system disorders | Non-systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D013927 | Thrombosis |
| D002241 |
| Carbohydrates |