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

Neurological Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01135862
• Other study ID #: CTIL-000-JR-08-TASMC
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 8, 2010
• Last updated: June 2, 2010
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Jonathan Roth
• Phone: 972-524262095
• Email: jonaroth[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspirin Treatment
• Brain Injuries
• Hemorrhage Growth
• Intracranial Hemorrhages
• Neurological Outcome
• Traumatic Intracranial Bleed

Intervention

Drug:
• platelets
6 packs of platelets will be administered

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours		6 hours	No
Primary	are lower aspirin doses a risk for early hemorrhagic growth		6 hours	No
Secondary	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.	within 1 month from platelet admission	Yes
Secondary	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.	within 1 week	Yes
Secondary	difference in neurological outcome between both groups	as evaluated by Glasgow Outcome Score (GOS)	1 month, 6 months, and 1 year after the traumatic brain injury	No