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Platelet Transfusion in Acute Intracerebral Hemorrhage

Primary Purpose

Intracerebral Hemorrhage

Status

Unknown status

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

platelets

About this trial

This is an interventional prevention trial for Intracerebral Hemorrhage focused on measuring Intracerebral hemorrhage, Hematoma enlargement, Antiplatelet agent, Platelet transfusion, Outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

being on either aspirin or clopidogrel or a combination of aspirin and dipyridamole
acute primary ICH
> 17 years
admitted within 6 h after onset of ICH
ICH score < 4

Exclusion Criteria:

other type of ICH than acute primary intracerebral hemorrhage
patients who need neurosurgery
life expectancy less than 3 months due to comorbid disorders
confirmed malignant disease (cancer)
confirmed acute myocardial infarction
hepatitis and/liver cirrhosis
renal failure
infectious disease (HIV, endocarditis etc.)
current or previous hematologic disease
women of childbearing age if pregnant
participation in another study within the preceding 30 days

Sites / Locations

Department of Neurology, Oulu University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

Platelet transfusion

No platelet transfusion

Outcomes

Primary Outcome Measures

Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT

Secondary Outcome Measures

Glasgow Outcome Score

Cardiovascular death occurring within the treatment period

Death due to any cause occurring within the treatment period

Acute myocardial infarction

Venous thromboembolism

Full Information

NCT ID

NCT00699621

First Posted

June 12, 2008

Last Updated

July 1, 2010

Sponsor

University of Oulu

Collaborators

University of Helsinki

1. Study Identification

Unique Protocol Identification Number

NCT00699621

Brief Title

Platelet Transfusion in Acute Intracerebral Hemorrhage

Official Title

Platelet Transfusion in Acute Primary Intracerebral Hemorrhage for Patients on Platelet Inhibitors

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

July 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Oulu

Collaborators

University of Helsinki

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To prove whether use of antiplatelet agents results into a rapid enlargement of hematoma after onset of acute intracerebral hemorrhage. To prove the efficacy and safety of platelet transfusion for prevention of hematoma growth in patients who were stricken by acute intracerebral hemorrhage while being on antiplatelet medication.

Detailed Description

Hematoma growth is a well-known powerful determinant of mortality and poor outcome after intracerebral hemorrhage. Some observations suggest that previous use of antiplatelet agents associates with rapid hematoma enlargement and poor outcome after cerebral hemorrhage. Immediate platelet transfusion for such patients may prevent hematoma growth but also cause thromboembolic complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracerebral Hemorrhage

Keywords

Intracerebral hemorrhage, Hematoma enlargement, Antiplatelet agent, Platelet transfusion, Outcome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Platelet transfusion

Arm Title

Arm Type

No Intervention

Arm Description

No platelet transfusion

Intervention Type

Biological

Intervention Name(s)

platelets

Intervention Description

Four units of fresh platelets will be infused immediately

Primary Outcome Measure Information:

Title

Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Glasgow Outcome Score

Time Frame

90 days

Title

Cardiovascular death occurring within the treatment period

Time Frame

90 days

Title

Death due to any cause occurring within the treatment period

Time Frame

90 days

Title

Acute myocardial infarction

Time Frame

90 days

Title

Venous thromboembolism

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: being on either aspirin or clopidogrel or a combination of aspirin and dipyridamole acute primary ICH > 17 years admitted within 6 h after onset of ICH ICH score < 4 Exclusion Criteria: other type of ICH than acute primary intracerebral hemorrhage patients who need neurosurgery life expectancy less than 3 months due to comorbid disorders confirmed malignant disease (cancer) confirmed acute myocardial infarction hepatitis and/liver cirrhosis renal failure infectious disease (HIV, endocarditis etc.) current or previous hematologic disease women of childbearing age if pregnant participation in another study within the preceding 30 days

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Matti E Hillbom, MD, PhD

Phone

358-8-315-4518

matti.hillbom@oulu.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Juha T Huhtakangas, MD

Phone

358-8-315-4032

juha.huhtakangas@ppshp.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matti E Hillbom, MD, PhD

Organizational Affiliation

Oulu University Central Hospital, Department of Neurology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Seppo S Juvela, MD, PhD

Organizational Affiliation

Turku University Central Hospital, Department of Neurosurgery

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Lauri Soinne, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital, Department of Neurology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Olli Häppölä, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Aimo Rissanen, MD, PhD

Organizational Affiliation

Keski-Suomen Keskussairaala

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Neurology, Oulu University Hospital

City

Oulu

ZIP/Postal Code

90029 OYS

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matti E Hillbom, MD, PhD

Phone

358-8-315-4518

matti.hillbom@oulu.fi

First Name & Middle Initial & Last Name & Degree

Juha T Huhtakangas, MD

Phone

358-8-315-4032

juha.huhtakangas@ppshp.fi

First Name & Middle Initial & Last Name & Degree

Juha T Huhtakangas, MD

First Name & Middle Initial & Last Name & Degree

Tarja T Haapaniemi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Sami T Tetri, MD

First Name & Middle Initial & Last Name & Degree

Michaela Bode, MD, PhD

First Name & Middle Initial & Last Name & Degree

Pertti Saloheimo, MD, PhD

First Name & Middle Initial & Last Name & Degree

Eeva-Riitta Savolainen, MD, PhD

12. IPD Sharing Statement

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Platelet Transfusion in Acute Intracerebral Hemorrhage

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