Platelet Transfusion in Acute Intracerebral Hemorrhage | NCT00699621

Studies
Platelet Transfusion in Acute Intracerebral Hemorrhage

NCT00699621

Sponsor

University of Oulu

Status

Unknown status

Last Update Posted

Jul 2, 2010Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Intracerebral Hemorrhage

Interventions

platelets

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jul 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Jun 12, 2008

First Submission Date that Met QC Criteria

Jun 17, 2008

First Posted Date

Jun 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2010

Last Update Posted Date

Jul 2, 2010Estimated

Name	Class
University of Helsinki	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Platelet transfusion	Biological: platelets
2	No Intervention	No platelet transfusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
platelets	Biological	Four units of fresh platelets will be infused immediately	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Glasgow Outcome Score		90 days
Cardiovascular death occurring within the treatment period		90 days
Death due to any cause occurring within the treatment period

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
Matti E Hillbom, MD, PhD	Oulu University Central Hospital, Department of Neurology	Study Chair
Seppo S Juvela, MD, PhD	Turku University Central Hospital, Department of Neurosurgery	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Oulu University Hospital	Recruiting	Oulu		90029 OYS	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37870112	Derived	Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D001772	Blood Cell Count
D002452	Cell Count
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques