Platelet Function Analysis in Head Trauma: ASA/Plavix

Chang, Steve S., M.D.

Status: Completed

Conditions: Head Injury Trauma Blunt

Treatments: Drug: DDAVP; Biological: Platelets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01534117

ASA/Plavix/Platelets_SBCH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

97 participants in 2 patient groups

Platelets/DDAVP

Active Comparator group

Description:

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

Treatment:

Biological: Platelets

Drug: DDAVP

No Platelets

No Intervention group

Description:

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