Platelet Function Analysis in Head Trauma: ASA/Plavix

Head Injury Trauma Blunt Clinical Trial

— ASA/Plavix  

Official title:

Platelet Function Analysis in Head Trauma: ASA/CLOPIDOGREL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534117
• Other study ID #: ASA/Plavix/Platelets_SBCH
• Status: Completed
• Phase: N/A
• First received: February 8, 2012
• Last updated: February 15, 2012
• Start date: October 2009
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: Chang, Steve S., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Head Injury Trauma Blunt
• Wounds and Injuries

Intervention

Biological:
• Platelets
1 unit of platelets

Drug:
• DDAVP
Desmopressin 0.3mcg/kg IV x 1

Locations

Country	Name	City	State
United States	Santa Barbara Cottage Hospital	Santa Barbara	California

Sponsors (3)

Lead Sponsor	Collaborator
Chang, Steve S., M.D.	Accumetrics, Inc., Santa Barbara Cottage Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet inhibition	We are measuring platelet inhibition using the verify now platelet function analyzer	8 hours	No