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

Primary Purpose

Aspirin Treatment, Traumatic Intracranial Bleed, Hemorrhage Growth

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
platelets
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aspirin Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tel-Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

platelet administered

no platelets administered

Arm Description

patients will receive 6 packs of platelets

patients will not receive platelets

Outcomes

Primary Outcome Measures

efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours
are lower aspirin doses a risk for early hemorrhagic growth

Secondary Outcome Measures

vascular complications
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
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
as evaluated by Glasgow Outcome Score (GOS)

Full Information

First Posted
March 8, 2010
Last Updated
June 2, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01135862
Brief Title
Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
Official Title
Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspirin Treatment, Traumatic Intracranial Bleed, Hemorrhage Growth, Neurological Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
platelet administered
Arm Type
Experimental
Arm Description
patients will receive 6 packs of platelets
Arm Title
no platelets administered
Arm Type
No Intervention
Arm Description
patients will not receive platelets
Intervention Type
Drug
Intervention Name(s)
platelets
Intervention Description
6 packs of platelets will be administered
Primary Outcome Measure Information:
Title
efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours
Time Frame
6 hours
Title
are lower aspirin doses a risk for early hemorrhagic growth
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
vascular complications
Description
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.
Time Frame
within 1 month from platelet admission
Title
complications attributed to platelets as listed below
Description
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.
Time Frame
within 1 week
Title
difference in neurological outcome between both groups
Description
as evaluated by Glasgow Outcome Score (GOS)
Time Frame
1 month, 6 months, and 1 year after the traumatic brain injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Roth
Phone
972-524262095
Email
jonaroth@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Roth, MD
Organizational Affiliation
Tel-Aviv Sorasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Roth, MD
Phone
972-524262095
Email
jonaroth@gmail.com

12. IPD Sharing Statement

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

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