Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage - Full Text View

Purpose

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.

Condition	Intervention	Phase
Intracerebral Hemorrhage	Drug: enoxaparin Drug: enoxaparin placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	A Double-blind Randomized Trial to Compare the Efficacy of Intermittent Pneumatic Compression (IPC) With and Without Early Anticoagulant Treatment for Prevention of Venous Thromboembolism (VTE) in Patients With Acute Primary Intracerebral Hemorrhage (ICH)

Resource links provided by NLM:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

MedlinePlus related topics: Bleeding

U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:

The cumulative occurrence of confirmed VTE, defined as the composite of symptomatic or asymptomatic DVT, or symptomatic or fatal PE occurring during the treatment period. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bleeding complications including rebleedings occurring within the treatment period [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Increase in ICH volume observed by head CT or at autopsy during the treatment period [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Cardiovascular death occurring within the treatment period [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Death due to any cause occurring within the treatment period [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	320
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Early enoxaparin	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. Other Names: Klexane Kendall
Placebo Comparator: 2 Late enoxaparin	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. Other Names: Klexane Kendall

Detailed Description:

Although it has been poorly investigated, the risk of VTE among patients with acute primary intracerebral hemorrhage is generally believed to be at least as high as among patients with ischemic stroke.
The currently available guidelines state that while low doses of subcutaneous heparin or low-molecular-weight heparin may reduce VTE, it is possible that their effect is counterbalanced by an increase in hemorrhagic complications.
It is still unclear when (if ever) low-molecular-weight-heparin should be safely initiated in ICH patients.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

acute primary ICH
> 17 years
unable to walk
admitted within 12 h after onset of ICH
informed consent obtained

Exclusion Criteria:

other type of ICH than acute primary intracerebral hemorrhage
patients who need neurosurgery
evidence of VTE at screening
thrombolytic treatment within the preceding week
major surgery or major trauma within the preceding 3 months
life expectancy less than 3 months due to comorbid disorders
confirmed malignant disease (cancer)
hepatitis and/or liver cirrhosis
renal failure
infectious disease (HIV, endocarditis etc.)
current of previous hematologic disease
recent active and untreated gastric/duodenal ulcer
allergy or known hypersensitivity to enoxaparin or heparins
known hypersensitivity to benzyl alcohol
women of childbearing age if pregnant
participation in another study within the preceding 30 days

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699465

Contacts


Contact: Matti E Hillbom, MD, PhD	358-8-315-4518	matti.hillbom@oulu.fi
Contact: Juha T Huhtakangas, MD	358-8-315-4032	juha.huhtakangas@ppshp.fi

Locations


Finland
Department of Neurology, Oulu University Hospital	Recruiting
Oulu, Finland, 90029 OYS
Contact: Matti E Hillbom, professor 358-8-315-4518 matti.hillbom@oulu.fi
Contact: Juha T Huhtakangas, MD 358-8-315-4032 juha.huhtakangas@ppshp.fi
Sub-Investigator: Tarja H Haapaniemi, MD, PhD
Sub-Investigator: Sami T Tetri, MD
Sub-Investigator: Michaela Bode, MD, PhD
Sub-Investigator: Pertti Saloheimo, MD, PhD
Sub-Investigator: Eeva-Riitta Savolainen, MD, PhD

Sponsors and Collaborators

University of Oulu

Helsinki University

Investigators


Study Chair:	Matti E Hillbom, MD, PhD	Oulu University Central Hospital, Department of Neurology
Study Director:	Seppo S Juvela, MD, PhD	Turku University Central Hospital, Department of Neurosurgery
Principal Investigator:	Turgut Tatlisumak, MD, PhD	Helsinki University Central Hospital, Department of Neurology
Principal Investigator:	Liisa K Luostarinen, MD, PhD	Päijät-Häme Central Hospital, Department of Neurology
Principal Investigator:	Aimo Rissanen, MD, PhD	Keski-Suomen Keskussairaala
Principal Investigator:	Heikki Numminen, MD, PhD	Tampere University Hospital

More Information

Publications:

Steiner T, Kaste M, Forsting M, Mendelow D, Kwiecinski H, Szikora I, Juvela S, Marchel A, Chapot R, Cognard C, Unterberg A, Hacke W. Recommendations for the management of intracranial haemorrhage - part I: spontaneous intracerebral haemorrhage. The European Stroke Initiative Writing Committee and the Writing Committee for the EUSI Executive Committee. Cerebrovasc Dis. 2006;22(4):294-316. Epub 2006 Jul 28. Erratum in: Cerebrovasc Dis. 2006;22(5-6):461. Katse, Markku [corrected to Kaste, Markku].

Broderick J, Connolly S, Feldmann E, Hanley D, Kase C, Krieger D, Mayberg M, Morgenstern L, Ogilvy CS, Vespa P, Zuccarello M; American Heart Association; American Stroke Association Stroke Council; High Blood Pressure Research Council; Quality of Care and Outcomes in Research Interdisciplinary Working Group. Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update: a guideline from the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group. Stroke. 2007 Jun;38(6):2001-23. Epub 2007 May 3.


Responsible Party:	Oulu University Hospital (Matti Hillbom), Oulu University Hospital
ClinicalTrials.gov Identifier:	NCT00699465 History of Changes
Other Study ID Numbers:	EUDRACT 2007-006206-24
Study First Received:	June 12, 2008
Last Updated:	July 1, 2010
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by University of Oulu:


Thromboprophylaxis Prevention of venous thromboembolism after ICH Enoxaparin Intermittent pneumatic compression

Additional relevant MeSH terms:


Hemorrhage Thromboembolism Venous Thromboembolism Cerebral Hemorrhage Pathologic Processes Embolism and Thrombosis Vascular Diseases	Cardiovascular Diseases Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on September 28, 2016