PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

NCT01573169 | Terminated Phase 3 Results DMC

• 1 other identifier: PREVENTIHS
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Stroke; Venous Thromboembolism; Deep Venous Thrombosis

Keywords

hemorrhagic stroke; venous thromboembolism; prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Bleedings

  90 days

• Mortality

  90 days

• Disability

  90 days

Study Arms (2)

low weight molecular heparin

EXPERIMENTAL

enoxaparin 0.4 ml subcutaneous per day

Drug: Enoxaparin

standard therapy

PLACEBO COMPARATOR

Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization

Other: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization

Interventions

Enoxaparin DRUG

enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke

low weight molecular heparin

Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization OTHER

placebo standard therapy

standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• cerebral hemorrhage due to intracranial vascular malformation
• rebleeding on CT scan after 72 hours from stroke (before randomization)

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Stroke Unit

Perugia, 06126, Italy

Location

Related Publications (3)

• 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.

  PMID: 21324058 BACKGROUND

• 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.

  PMID: 36700520 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.

  PMID: 33190135 DERIVED

MeSH Terms

Conditions

Hemorrhagic Stroke; Venous Thromboembolism; Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis; Thrombosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Maurizio Paciaroni
• Organization: Stroke Unit and Division of Internal and Cardiovascular Medicine University of Perugia, Santa Maria della Misericordia Hospital

maurizio.paciaroni@unipg.it

+390755786424

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2012
• First Posted: April 6, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 10, 2021
• Results First Posted: September 10, 2021

Record last verified: 2021-09

Locations

IT (1)