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

NCT01810276 | Terminated DMC

• 2 other identifiers: 60129131115
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if the administration of platelets will improve outcome in patients with ICH who are being treated with either aspirin, a thienopyridine (ticlodipine, clopidogrel, prasugrel) or a combination of both. The study has four specific aims:

1. 1.To determine what affect platelet administration will have on bleeding in the brain.
2. 2.To determine what affect platelet administration will have on brain function. Several assessments to test the functioning of the brain will be performed at enrollment and throughout the study. Comparing the results of these assessments between the experimental and control groups should allow us to determine if platelet administration improves outcomes in patients with bleeding in the brain exposed to antiplatelet therapy.
3. 3.An important risk of reversing antiplatelet therapy is exposing the patient to the very complications this therapy was designed to prevent. Therefore, tracking complications will be a very important part of this study. The investigators will compare the rates of death, heart attack, stroke and clots in the veins between groups.
4. 4.Some patients (10-40%) have limited responsiveness to antiplatelet therapy. While platelet responsiveness, as measured by a special platelet blood test, will not affect enrollment, the investigators feel it will be important to measure.

Conditions

Traumatic Head Injury; Intracranial Hemmorhage; Anti-platelet Therapy

Keywords

traumatic head injury; intracranial hemorrhage; platelets; anti-platelet therapy; plavix; asprin

Outcome Measures

Primary Outcomes (1)

• Hemorrhage growth

  Bleeding in the brain will be measured by computerized tomography scan (CT Scan) 24 hours after study treatment is completed.

  24 hours

Secondary Outcomes (1)

• Neurological Outcome

  Assessments to determine brain function or neurological outcome will be performed at enrollment, time of study treatment, 1 and 24 hours post treatment, days 2, 3, and 10 (or time of discharge) and at 90 days post treatment.

Other Outcomes (2)

• Thromboembolic complications

  Complications will be monitored enrollment, time of study treatment, 1 and 24 hours post treatment, days 2, 3, and 10 (or time of discharge)and at 90 days post treatment.

• Platelet responsiveness

  1 hour and 24 hours post study treatment

Study Arms (2)

Saline

PLACEBO COMPARATOR

400 mL of Saline will be given intravenously over 2 hours once.

Other: Saline

Platelets

ACTIVE COMPARATOR

2 apheresis units of platelets (approximately 200 ml) will be given intravenously over 2 hours.

Other: Platelets

Interventions

Saline OTHER

400 mL of Saline will be given intravenously over 2 hours once

Saline

Platelets OTHER

2 apheresis units of platelets (approximately 200 ml) will be given intravenously over 2 hours.

Platelets

Eligibility Criteria

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

You may qualify if:

• years or older
• Evidence of intracranial hemorrhage (bleeding in the brain) by CT scan related to traumatic injury
• Receiving antiplatelet therapy such as aspirin, thienopyridine (ticlopidine, clopidogrel, or prasugrel)
• Platelet count greater than or equal to 100,000

You may not qualify if:

• Glasgow Coma Scale (GCS) less than 6
• Hemorrhage requiring emergent surgery
• Lack of permission from treating physician and/or consultant
• Secondary ICH related to aneurysm or arteriovenous malformation
• Use of oral anticoagulants
• Decreased platelets (thrombocytopenia)
• Patients requiring massive transfusion protocol
• Life expectancy less than 3 months
• Confirmed acute heart attack
• Hepatitis and liver cirrhosis
• Kidney failure
• Participation in another treatment study within the preceding 30 days

Sponsors & Collaborators

• Christiana Care Health Services: lead
• United States Department of Defense: collaborator

Study Sites (1)

Christiana Care Health System, Christiana Hospital

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Intracranial Hemorrhages

Interventions

Sodium Chloride; Platelet Count

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; 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

• Mark Cipolle

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: March 13, 2013
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)