Platelet Function Analysis in Head Trauma: ASA/Plavix

• Sponsor: Chang, Steve S., M.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01534117
• Collaborator: Santa Barbara Cottage Hospital (Other), Accumetrics, Inc. (Industry)
• Enrollment: 97
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head Injury Trauma Blunt	Biological: Platelets; Drug: DDAVP	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Platelet Function Analysis in Head Trauma: ASA/CLOPIDOGREL
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Platelets/DDAVP Fall on ASA/Plavix that sustained head trauma requiring administration of platelets and/or DDAVP	Biological: Platelets; 1 unit of platelets; Drug: DDAVP; Desmopressin 0.3mcg/kg IV x 1
No Intervention: No Platelets Those that sustain head trauma NOT requiring platelet transfusion. The investigators are evaluating platelet function in those not requiring platelet transfusion

Outcome Measures

Primary Outcome Measures

1. Platelet inhibition [8 hours]

   We are measuring platelet inhibition using the verify now platelet function analyzer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santa Barbara Cottage Hospital	Santa Barbara	California	United States	93105

Sponsors and Collaborators

• Chang, Steve S., M.D.
• Santa Barbara Cottage Hospital
• Accumetrics, Inc.

Investigators

• Principal Investigator: Steve S Chang, MD, Santa Barbara Cottage Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang, Steve S., M.D.
• ClinicalTrials.gov Identifier: NCT01534117
• Other Study ID Numbers: ASA/Plavix/Platelets_SBCH
• First Posted: Feb 16, 2012
• Last Update Posted: Feb 16, 2012
• Last Verified: Feb 1, 2012

• Additional relevant MeSH terms: Craniocerebral Trauma; Wounds and Injuries

Study Results

No Results Posted as of Feb 16, 2012