Platelet Function Analysis in Head Trauma: ASA/Plavix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head Injury Trauma Blunt

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Platelets/DDAVP

Fall on ASA/Plavix that sustained head trauma requiring administration of platelets and/or DDAVP

Group Type ACTIVE_COMPARATOR

Platelets

Intervention Type BIOLOGICAL

1 unit of platelets

DDAVP

Intervention Type DRUG

Desmopressin 0.3mcg/kg IV x 1

No Platelets

Those that sustain head trauma NOT requiring platelet transfusion. The investigators are evaluating platelet function in those not requiring platelet transfusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Platelets

1 unit of platelets

Intervention Type BIOLOGICAL

DDAVP

Desmopressin 0.3mcg/kg IV x 1

Intervention Type DRUG

Eligibility Criteria

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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).