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

Platelet Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594345
• Other study ID #: ExoRBC
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: February 22, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• pregnancy

• drug use

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Coagulation
• Platelet Function

Intervention

Other:
• in vitro study
Exosomes will be mixed with healthy volunteers' blood in vitro

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clotting time	measured by thromboelastometry (ROTEM® Analysis)	2 months	No
Secondary	clot formation	measured by thromboelastometry (ROTEM® Analysis)	1h after exposure	No
Secondary	clot stability	measured by thromboelastometry (ROTEM® Analysis)	1h after exposure	No
Secondary	clot lysis	measured by thromboelastometry (ROTEM® Analysis)	1h after exposure	No
Secondary	CD62P	FACS analysis	3h after exposure	No