NCT00699621

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 2, 2010

Status Verified

July 1, 2010

Enrollment Period

5.5 years

First QC Date

June 12, 2008

Last Update Submit

July 1, 2010

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral hemorrhageHematoma enlargementAntiplatelet agentPlatelet transfusionOutcome

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Secondary Outcomes (5)

  • Glasgow Outcome Score

    90 days

  • Cardiovascular death occurring within the treatment period

    90 days

  • Death due to any cause occurring within the treatment period

    90 days

  • Acute myocardial infarction

    90 days

  • Venous thromboembolism

    90 days

Study Arms (2)

1

ACTIVE COMPARATOR

Platelet transfusion

Biological: platelets

2

NO INTERVENTION

No platelet transfusion

Interventions

plateletsBIOLOGICAL

Four units of fresh platelets will be infused immediately

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Oulu University Hospital

Oulu, 90029 OYS, Finland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37870112DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsPlatelet Function TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • 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

  • Lauri Soinne, MD, PhD

    Helsinki University Central Hospital, Department of Neurology

    PRINCIPAL INVESTIGATOR

  • Olli Häppölä, MD, PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

  • Aimo Rissanen, MD, PhD

    Keski-Suomen Keskussairaala

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matti E Hillbom, MD, PhD

CONTACT

358-8-315-4518matti.hillbom@oulu.fi

Juha T Huhtakangas, MD

CONTACT

358-8-315-4032juha.huhtakangas@ppshp.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 18, 2008

Study Start

January 1, 2009

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

July 2, 2010

Record last verified: 2010-07

Locations

FI(1)