Platelet Function Analysis in Head Trauma: ASA/Plavix
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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 |
- 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 |
Inclusion Criteria:
- Age > 18yrs
- Must be a trauma patient with blunt head trauma.
- Must be on Aspirin and/or Plavix
- 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:
- Hemoglobin ≤ 10 GM/DL
- Platelet Count ≤ 150 K/MCL
- Pregnant Females
- Subjects on Warfarin, Heparin or Enoxaparin
Contacts and Locations| United States, California | |
| Santa Barbara Cottage Hospital | |
| Santa Barbara, California, United States, 93105 | |
| 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 Antidiuretic Agents Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013