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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01135862
First received: March 8, 2010
Last updated: June 2, 2010
Last verified: June 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • are lower aspirin doses a risk for early hemorrhagic growth [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vascular complications [ Time Frame: within 1 month from platelet admission ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 8, 2010
Last Updated: June 2, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hemorrhage
Intracranial Hemorrhages
Brain Injuries
Wounds and Injuries
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 25, 2014