Platelet Function Analysis in Head Trauma: ASA/Plavix

NCT01534117 | Completed DMC

• 1 other identifier: ASA/Plavix/Platelets_SBCH
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Injury Trauma Blunt

Outcome Measures

Primary Outcomes (1)

• Platelet inhibition

  We are measuring platelet inhibition using the verify now platelet function analyzer

  8 hours

Study Arms (2)

Platelets/DDAVP

ACTIVE COMPARATOR

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

Biological: Platelets; Drug: DDAVP

No Platelets

NO INTERVENTION

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

Interventions

Platelets BIOLOGICAL

1 unit of platelets

Platelets/DDAVP

DDAVP DRUG

Desmopressin 0.3mcg/kg IV x 1

Platelets/DDAVP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Hemoglobin ≤ 10 GM/DL
• Platelet Count ≤ 150 K/MCL
• Pregnant Females
• Subjects on Warfarin, Heparin or Enoxaparin

Sponsors & Collaborators

• Chang, Steve S., M.D.: lead
• Santa Barbara Cottage Hospital: collaborator
• Accumetrics, Inc.: collaborator

Study Sites (1)

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Interventions

Platelet Count; Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Steve S Chang, MD

  Santa Barbara Cottage Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 16, 2012
• Study Start: October 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 16, 2012

Record last verified: 2012-02

Locations

US (1)