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

NCT01135862 | Unknown Phase 2 DMC

• 1 other identifier: CTIL-000-JR-08-TASMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspirin Treatment; Traumatic Intracranial Bleed; Hemorrhage Growth; Neurological Outcome

Outcome Measures

Primary Outcomes (2)

• efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours

  6 hours

• are lower aspirin doses a risk for early hemorrhagic growth

  6 hours

Secondary Outcomes (3)

• vascular complications

  within 1 month from platelet admission

• complications attributed to platelets as listed below

  within 1 week

• difference in neurological outcome between both groups

  1 month, 6 months, and 1 year after the traumatic brain injury

Study Arms (2)

platelet administered

EXPERIMENTAL

patients will receive 6 packs of platelets

Drug: platelets

no platelets administered

NO INTERVENTION

patients will not receive platelets

Drug: platelets

Interventions

platelets DRUG

6 packs of platelets will be administered

no platelets administered; platelet administered

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Interventions

Platelet Count

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Jonathan Roth, MD

  Tel-Aviv Sorasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Roth

CONTACT

972-524262095; jonaroth@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: June 3, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2013
• Last Updated: June 3, 2010

Record last verified: 2010-06

Locations

IL (1)