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Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01135862
First Posted: June 3, 2010
Last Update Posted: June 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose

Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones).

Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed.

In this prospective study, the investigators randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets.

The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.


Condition Intervention Phase
Aspirin Treatment Traumatic Intracranial Bleed Hemorrhage Growth Neurological Outcome Drug: platelets Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours [ Time Frame: 6 hours ]
  • are lower aspirin doses a risk for early hemorrhagic growth [ Time Frame: 6 hours ]

Secondary Outcome Measures:
  • vascular complications [ Time Frame: within 1 month from platelet admission ]
    vascular complications include active ischemic heart disease (MI, unstable angina), ischemic stroke, acute peripheral vasculopathy, deep vein thrombosis, and pulmonary emboli these complications will be diagnosed clinically and not by screening procedures.

  • complications attributed to platelets as listed below [ Time Frame: within 1 week ]

    these complications include an exacerbation of congestive heart failure, or any allergic reaction to platelet admission such as fever, rigor, rash, hemodynamic collapse occuring within 6 hours of platelet admission.

    other events which will be attributed to platelet admission are sepsis <48 hours after platelet admission or new thrombocytopenia occurring within 1 week after admission of platelets.


  • difference in neurological outcome between both groups [ Time Frame: 1 month, 6 months, and 1 year after the traumatic brain injury ]
    as evaluated by Glasgow Outcome Score (GOS)


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: platelet administered
patients will receive 6 packs of platelets
Drug: platelets
6 packs of platelets will be administered
No Intervention: no platelets administered
patients will not receive platelets
Drug: platelets
6 packs of platelets will be administered

Detailed Description:

Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones).

Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed.

In this prospective study, we randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets.

The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >18 years old
  • chronic aspirin treatment
  • first CT scan less than 12 hours following the trauma
  • GCS >3
  • no immediate surgical cranial lesion
  • isolated head injury
  • consent
  • contusions >1.5cc or acute subdural hemorrhage in any size

Exclusion Criteria:

  • anticoagulation treatment
  • more than one antiaggregate
  • coagulopathy
  • thrombocytopenia (less than 100000)
  • intracranial tumor
  • active hematological disease
  • more than 8 hours between first and second CT scan
  • more than 2 hours between first CT and platelet admission
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135862


Contacts
Contact: Jonathan Roth 972-524262095 jonaroth@gmail.com

Locations
Israel
Tel-Aviv Sourasky Medical Center Not yet recruiting
Tel-Aviv, Israel
Contact: Jonathan Roth, MD    972-524262095    jonaroth@gmail.com   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Jonathan Roth, MD Tel-Aviv Sorasky Medical Center
  More Information

Responsible Party: Department of Neurosurgery, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01135862     History of Changes
Other Study ID Numbers: CTIL-000-JR-08-TASMC
First Submitted: March 8, 2010
First Posted: June 3, 2010
Last Update Posted: June 3, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Brain Injuries
Hemorrhage
Brain Injuries, Traumatic
Intracranial Hemorrhages
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics