Platelet Function Analysis in Head Trauma: ASA/Plavix

What Was Tested

The trial (not phased) is built around Desmopressin.

It had two arms (groups): Platelets/DDAVP (active comparator) and No Platelets (no intervention).

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

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

The registry classes the interventions as biological and drug.

More on the Plan

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.

Their 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.

Who Took Part

The registry lists 97 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age \> 18yrs. Must be a trauma patient with blunt head trauma. Must be on Aspirin and/or Plavix.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: hemoglobin ≤ 10 gm/dl; platelet count ≤ 150 k/mcl; pregnant females.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Desmopressin study: the participants and staff both knew the treatment.

It started in 2009-10 with completion listed for 2011-11.

It ran at 1 site in United States.

What Was Measured

Primary outcome: Platelet inhibition (time frame: 8 hours).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Desmopressin in 97 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.