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Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

NCT00699465 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2010-07-02

No results posted yet for this study

Summary

* To evaluate the efficacy of using IPC during the acute phase of ICH in the prevention of VTE.
* To assess the safety and efficacy of additional therapy with enoxaparin.
* To compare the efficacy and safety of the European and American guideline recommendations.
* To provide an efficient and safe thromboprophylaxis for several weeks until the patient is able to walk.

Conditions

  • Intracerebral Hemorrhage

Interventions

DRUG

enoxaparin

20 mg enoxaparin (2 000 IU) s.c. will be given twice daily starting 24-48 h after onset of the stroke. Intermittent pneumatic compression will be started immediately after admission.

DRUG

enoxaparin placebo

Placebo will be given s.c. twice daily starting 24-48 h after onset of the stroke for 2 days. Thereafter, 20 mg enoxaparin (2 000 IU) s.c. will be given twice daily. Intermittent pneumatic compression will be started immediately after admission.

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • University of Oulu

    lead OTHER

Principal Investigators

  • Matti E Hillbom, MD, PhD · Oulu University Central Hospital, Department of Neurology

  • Seppo S Juvela, MD, PhD · Turku University Central Hospital, Department of Neurosurgery

  • Turgut Tatlisumak, MD, PhD · Helsinki University Central Hospital, Department of Neurology

  • Liisa K Luostarinen, MD, PhD · Päijät-Häme Central Hospital, Department of Neurology

  • Aimo Rissanen, MD, PhD · Keski-Suomen Keskussairaala

  • Heikki Numminen, MD, PhD · Tampere University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2013-07-31
Completion
2013-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00699465 on ClinicalTrials.gov