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

March 8, 2010
June 2, 2010
June 2010
June 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01135862 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aspirin Treatment
  • Traumatic Intracranial Bleed
  • Hemorrhage Growth
  • Neurological Outcome
Drug: platelets
6 packs of platelets will be administered
  • Experimental: platelet administered
    patients will receive 6 packs of platelets
    Intervention: Drug: platelets
  • No Intervention: no platelets administered
    patients will not receive platelets
    Intervention: Drug: platelets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
June 2013
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jonathan Roth 972-524262095 jonaroth@gmail.com
Israel
 
NCT01135862
CTIL-000-JR-08-TASMC
Yes
Department of Neurosurgery, Tel Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Jonathan Roth, MD Tel-Aviv Sorasky Medical Center
Tel-Aviv Sourasky Medical Center
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP