NCT02594345

Brief Summary

This study is designed to analyze the effect exosomes derived from red blood cell units have on blood coagulation and platelet function. It is an in vitro study using healthy volunteers' blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

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

October 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2 months

First QC Date

October 30, 2015

Last Update Submit

February 22, 2016

Conditions

Blood CoagulationPlatelet Function

Outcome Measures

Primary Outcomes (1)

  • clotting time

    measured by thromboelastometry (ROTEM® Analysis)

    2 months

Secondary Outcomes (4)

  • clot formation

    1h after exposure

  • clot stability

    1h after exposure

  • clot lysis

    1h after exposure

  • CD62P

    3h after exposure

Study Arms (1)

Intervention group

EXPERIMENTAL
Other: in vitro study

Interventions

in vitro studyOTHER

Exosomes will be mixed with healthy volunteers' blood in vitro

Intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • pregnancy
  • drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Dania P Fischer, M.D.

    Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research associate

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 3, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

DE(1)