Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation

February 22, 2016 updated by: Dr Dania Fischer, Johann Wolfgang Goethe University Hospital

In Vitro Study of the Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation in Healthy Volunteers' Blood

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The blood of 25 healthy volunteers will be exposed to exosomes derived from red blood cell units. The effects on coagulation and platelet function will be measured using thromboelastometry (ROTEM®) and FACS analysis.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • pregnancy
  • drug use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Other: in vitro study
Exosomes will be mixed with healthy volunteers' blood in vitro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clotting time
Time Frame: 2 months
measured by thromboelastometry (ROTEM® Analysis)
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clot formation
Time Frame: 1h after exposure
measured by thromboelastometry (ROTEM® Analysis)
1h after exposure
clot stability
Time Frame: 1h after exposure
measured by thromboelastometry (ROTEM® Analysis)
1h after exposure
clot lysis
Time Frame: 1h after exposure
measured by thromboelastometry (ROTEM® Analysis)
1h after exposure
CD62P
Time Frame: 3h after exposure
FACS analysis
3h after exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Dania P Fischer, M.D., Goethe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • ExoRBC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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