Platelet Function Analysis in Head Trauma: ASA/Plavix

Not Applicable

Completed

• Conditions: Head Injury Trauma Blunt
• Interventions: Biological: Platelets; Drug: DDAVP

• Registration Number: NCT01534117
• Lead Sponsor: Chang, Steve S., M.D.

Brief Summary

The investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered.

Detailed Description

The platelet function analyzer VerifyNow® P2Y12 uses ADP as agonists to induce platelet activation and ascertain the level of platelet function impaired by these medications. VerifyNow® Aspirin Assay utilizes arachidonic acid as the agonist to measure platelet function specifically along this pathway. Our research question for this study is as follows:

Does the administration of desmopressin (DDAVP) and/or the transfusion of platelets in patients with head trauma reverse the platelet inhibition caused by Aspirin and/or Plavix? The investigators hypothesize that with the administration of platelets and/or DDAVP that there is a reversal of the inhibition.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-02
• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-15
• Last Update Submitted: 2012-02-15
• Study First Posted: 2012-02-16
• Last Update Posted: 2012-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

1. Age > 18yrs
2. Must be a trauma patient with blunt head trauma.
3. Must be on Aspirin and/or Plavix
4. Subject or Legally Authorized Representative (LAR) (per Heath and Safety Code, Sections 24170 to 24179.5) must sign study consent within 4 hours from the first blood draw. (If this criterion is not met the initial blood draw must be destroyed and NOT run for study results).

Exclusion Criteria

1. Hemoglobin ≤ 10 GM/DL
2. Platelet Count ≤ 150 K/MCL
3. Pregnant Females
4. Subjects on Warfarin, Heparin or Enoxaparin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelets/DDAVP	Platelets	Fall on ASA/Plavix that sustained head trauma requiring administration of platelets and/or DDAVP
Platelets/DDAVP	DDAVP	Fall on ASA/Plavix that sustained head trauma requiring administration of platelets and/or DDAVP

Primary Outcome Measures

Name	Time	Method
Platelet inhibition	8 hours	We are measuring platelet inhibition using the verify now platelet function analyzer

Trial Locations

Locations (1)

Santa Barbara Cottage Hospital; 🇺🇸 Santa Barbara, California, United States