Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
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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 |
- 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 ]
- 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 |
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| Contact: Jonathan Roth | 972-524262095 | jonaroth@gmail.com |
| Israel | |
| Tel-Aviv Sourasky Medical Center | Not yet recruiting |
| Tel-Aviv, Israel | |
| Contact: Jonathan Roth, MD 972-524262095 jonaroth@gmail.com | |
| 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 Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013