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Platelet Function Analysis in Head Trauma: ASA/Plavix (ASA/Plavix)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01534117
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : February 16, 2012
Santa Barbara Cottage Hospital
Accumetrics, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Head Injury Trauma Blunt Biological: Platelets Drug: DDAVP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

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

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

Primary Outcome Measures :
  1. Platelet inhibition [ Time Frame: 8 hours ]
    We are measuring platelet inhibition using the verify now platelet function analyzer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01534117

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United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Chang, Steve S., M.D.
Santa Barbara Cottage Hospital
Accumetrics, Inc.
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Principal Investigator: Steve S Chang, MD Santa Barbara Cottage Hospital
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Responsible Party: Chang, Steve S., M.D. Identifier: NCT01534117    
Other Study ID Numbers: ASA/Plavix/Platelets_SBCH
First Posted: February 16, 2012    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases