NCT01248351

Brief Summary

The objective of the study is to test the hypothesis whether or not autologous stored platelets are able to offset the antiplatelet effect of aspirin and clopidogrel as assessed by state-of-the-art platelet function assays.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2011

Enrollment Period

3 months

First QC Date

November 19, 2010

Last Update Submit

April 27, 2011

Conditions

Bleeding

Keywords

aspirin, clopidogrel, pharmacodynamics, platelet transfusion

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamic assessment of platelet function as assessed by 5 and 20 micromolar ADP

    pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter

    7 days

Secondary Outcomes (3)

  • Pharmacodynamic assessment of platelet function as assessed by 20 mM arachidonic acid

    7 days

  • Pharmacodynamic assessment of platelet function as assessed by Vasodilator stimulated phosphoprotein (VASP) phosphorylation (platelet reactivity index; PRI)

    7 days

  • Pharmacodynamic assessment of platelet function as assessed by expression of GP IIb/IIIa receptors and P-selectin (Mean fluorescence intensity %)

    7 days

Study Arms (1)

autologous stored platelets

EXPERIMENTAL
Other: autologous stored plateletsOther: administration of autologous stored plateletsBiological: autologous stored platelets

Interventions

autologous stored plateletsOTHER

Administration of autologous stored platelets

autologous stored platelets
administration of autologous stored plateletsOTHER

administration of autologous stored platelets

autologous stored platelets

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent
  • Age of consent
  • Weight: 70 kg - 100 kg
  • Platelet count 240 000 to 440 000/µL
  • Hematocrit \> 40%
  • readiness to refrain from any activities prone to injury during the study period.

You may not qualify if:

  • Allergy against aspirin or clopidogrel
  • History of bleeding
  • History of peptic ulcer
  • Intake of aspirin or NSAR during the last ten days before screening
  • Gastrointestinal disease precluding resorption of aspirin and clopidogrel
  • Scheduled surgery
  • Any current medication
  • History of hepatic disease
  • µm ADP induced aggregation \< 60% at screening
  • CYP2C19 polymorphisms
  • Donation of blood within the preceding 4 weeks
  • Neurotic disease
  • Current smoking
  • Drug addiction
  • Intake of grapefruits during the last 10 days before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anesthesia and intensive care medicine, Medical Univerity of Graz

Graz, 8036, Austria

Location

Related Publications (1)

  • Pruller F, Drexler C, Archan S, Macher S, Raggam RB, Mahla E. Low platelet reactivity is recovered by transfusion of stored platelets: a healthy volunteer in vivo study. J Thromb Haemost. 2011 Aug;9(8):1670-3. doi: 10.1111/j.1538-7836.2011.04392.x. No abstract available.

    PMID: 21649849DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mahla Elisabeth, MD

    Dept. of Anesthesia and Intensive Care Medicine, Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 25, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

April 28, 2011

Record last verified: 2011-04

Locations

AU(1)