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Platelet Function Analysis in Head Trauma: ASA/Plavix

Platelet Function Analysis in Head Trauma: ASA/CLOPIDOGREL

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01534117
Acronym
ASA/Plavix
Enrollment
97
Registered
2012-02-16
Start date
2009-10-31
Completion date
2011-11-30
Last updated
2012-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Injury Trauma Blunt

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.

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.

Interventions

BIOLOGICALPlatelets

1 unit of platelets

DRUGDDAVP

Desmopressin 0.3mcg/kg IV x 1

Sponsors

Santa Barbara Cottage Hospital
CollaboratorOTHER
Accumetrics, Inc.
CollaboratorINDUSTRY
Chang, Steve S., M.D.
Lead SponsorINDIV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Platelet inhibition8 hoursWe are measuring platelet inhibition using the verify now platelet function analyzer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026