Platelet Function Analysis in Head Trauma: ASA/Plavix

This study has been completed.
Sponsor:
Collaborators:
Santa Barbara Cottage Hospital
Accumetrics, Inc.
Information provided by (Responsible Party):
Chang, Steve S., M.D.
ClinicalTrials.gov Identifier:
NCT01534117
First received: February 8, 2012
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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 Intervention
Head Injury Trauma Blunt
Biological: Platelets
Drug: DDAVP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Platelet Function Analysis in Head Trauma: ASA/CLOPIDOGREL

Resource links provided by NLM:


Further study details as provided by Chang, Steve S., M.D.:

Primary Outcome Measures:
  • Platelet inhibition [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    We are measuring platelet inhibition using the verify now platelet function analyzer


Enrollment: 97
Study Start Date: October 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Platelets
Drug: DDAVP
Desmopressin 0.3mcg/kg IV x 1
Other Name: DDAVP
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01534117

Locations
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.
Investigators
Principal Investigator: Steve S Chang, MD Santa Barbara Cottage Hospital
  More Information

No publications provided

Responsible Party: Chang, Steve S., M.D.
ClinicalTrials.gov Identifier: NCT01534117     History of Changes
Other Study ID Numbers: ASA/Plavix/Platelets_SBCH
Study First Received: February 8, 2012
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Craniocerebral Trauma
Wounds and Injuries
Wounds, Nonpenetrating
Trauma, Nervous System
Nervous System Diseases
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014