Intracerebral HemorrhagePhase 4NCT00699465
Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage
A Phase 4 study testing enoxaparin in people with Intracerebral Hemorrhage, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- enoxaparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2008to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute primary ICH
- > 17 years
- unable to walk
- admitted within 12 h after onset of ICH
- informed consent obtained
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Department of Neurology, Oulu University Hospital
Oulu, 90029 OYS
Matti E Hillbom, professor, 358-8-315-4518, matti.hillbom@oulu.fi
Juha T Huhtakangas, MD, 358-8-315-4032, juha.huhtakangas@ppshp.fi
About this study
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)
- 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.
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- enoxaparin, enoxaparin placebo
- Keywords
- Thromboprophylaxis, Prevention of venous thromboembolism after ICH, Enoxaparin, Intermittent pneumatic compression
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enoxaparinDrug
Also called Klexane, Kendall
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.
enoxaparin placeboDrug
Also called Klexane, Kendall
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Early enoxaparin Receives: Drug: enoxaparin |
| 2 | Placebo comparator | Late enoxaparin Receives: Drug: enoxaparin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (4)
Bleeding complications including rebleedings occurring within the treatment period
Measured: 90 days
Increase in ICH volume observed by head CT or at autopsy during the treatment period
Measured: 90 days
Cardiovascular death occurring within the treatment period
Measured: 90 days
Death due to any cause occurring within the treatment period
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Investigators
- Matti E Hillbom, MD, PhD, Study chair, Oulu University Central Hospital, Department of NeurologySeppo S Juvela, MD, PhD, Study director, Turku University Central Hospital, Department of NeurosurgeryTurgut Tatlisumak, MD, PhD, Principal investigator, Helsinki University Central Hospital, Department of NeurologyLiisa K Luostarinen, MD, PhD, Principal investigator, Päijät-Häme Central Hospital, Department of NeurologyAimo Rissanen, MD, PhD, Principal investigator, Keski-Suomen KeskussairaalaHeikki Numminen, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699465
- Sponsor's protocol ID
- EUDRACT 2007-006206-24
- Status last verified
- Jul 2010
- First submitted
- 12 Jun 2008
- Last updated
- 2 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1159/000094831. Epub 2006 Jul 28.
PubMed 16926557Broderick 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. doi: 10.1161/STROKEAHA.107.183689. Epub 2007 May 3.
PubMed 17478736
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00699465
- Acronym / sponsor ID
- EUDRACT 2007-006206-24
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Thromboprophylaxis, Prevention of venous thromboembolism after ICH, Enoxaparin, Intermittent pneumatic compression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- Aug 2008
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: enoxaparinEarly enoxaparin |
| 2 | Placebo comparator | Drug: enoxaparin placeboLate enoxaparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- acute primary ICH
- > 17 years
- unable to walk
- admitted within 12 h after onset of ICH
- informed consent obtained
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enoxaparinAlso: Klexane, Kendall20 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 | 1 |
| enoxaparin placeboAlso: Klexane, KendallPlacebo 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. | Drug | 2 |
Primary outcome
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
4 secondary outcomes
Bleeding complications including rebleedings occurring within the treatment period
Time frame: 90 days
Increase in ICH volume observed by head CT or at autopsy during the treatment period
Time frame: 90 days
Cardiovascular death occurring within the treatment period
Time frame: 90 days
Death due to any cause occurring within the treatment period
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2010.
- Background: PubMed 16926557Steiner 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. doi: 10.1159/000094831. Epub 2006 Jul 28.
- Background: PubMed 17478736Broderick 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. doi: 10.1161/STROKEAHA.107.183689. Epub 2007 May 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matti E Hillbom, MD, PhD study chair
Oulu University Central Hospital, Department of Neurology
Seppo S Juvela, MD, PhD study director
Turku University Central Hospital, Department of Neurosurgery
Turgut Tatlisumak, MD, PhD principal investigator
Helsinki University Central Hospital, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing enoxaparin in people with Intracerebral Hemorrhage, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matti E Hillbom, MD, PhD (358-8-315-4518, matti.hillbom@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699465, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2010.