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

Not Applicable

Completed

• Conditions: Blood Coagulation; Platelet Function
• Interventions: Other: in vitro study

• Registration Number: NCT02594345
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

• pregnancy
• drug use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	in vitro study	-

Primary Outcome Measures

Name	Time	Method
clotting time	2 months	measured by thromboelastometry (ROTEM® Analysis)

Secondary Outcome Measures

Name	Time	Method
clot formation	1h after exposure	measured by thromboelastometry (ROTEM® Analysis)
clot stability	1h after exposure	measured by thromboelastometry (ROTEM® Analysis)
clot lysis	1h after exposure	measured by thromboelastometry (ROTEM® Analysis)
CD62P	3h after exposure	FACS analysis

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt am Main, Hessen, Germany