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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?

NCT01470040

Head Trauma Traumatic Brain Injury Chronic Subdural Hematoma

UNKNOWN PHASE4

Safety of Platelet Transfusion in Patients on Antiplatelet Therapy With Traumatic Head Injury

NCT01810276

Traumatic Head Injury Intracranial Hemmorhage Anti-platelet Therapy

TERMINATED NA

Platelet Transfusion in Acute Intracerebral Hemorrhage

NCT00699621

Intracerebral Hemorrhage

UNKNOWN NA

Chronic Subdural Hematoma and Aspirin

NCT03120182

Chronic Subdural Hematoma

COMPLETED NA

Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage

NCT04820972

Spontaneous Intracerebral Hemorrhage

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aspirin Treatment Traumatic Intracranial Bleed Hemorrhage Growth Neurological Outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

platelet administered

patients will receive 6 packs of platelets

Group Type EXPERIMENTAL

platelets

Intervention Type DRUG

6 packs of platelets will be administered

no platelets administered

patients will not receive platelets

Group Type NO_INTERVENTION

platelets

Intervention Type DRUG

6 packs of platelets will be administered

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

platelets

6 packs of platelets will be administered

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No