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

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02594345
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Coagulation; Platelet Function	Other: in vitro study	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. clotting time [2 months]

   measured by thromboelastometry (ROTEM® Analysis)

Secondary Outcome Measures

1. clot formation [1h after exposure]

   measured by thromboelastometry (ROTEM® Analysis)

2. clot stability [1h after exposure]

   measured by thromboelastometry (ROTEM® Analysis)

3. clot lysis [1h after exposure]

   measured by thromboelastometry (ROTEM® Analysis)

4. CD62P [3h after exposure]

   FACS analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• pregnancy

• drug use

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Frankfurt	Frankfurt am Main	Hessen	Germany	60590

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Dania Fischer, Research associate, Johann Wolfgang Goethe University Hospital
• ClinicalTrials.gov Identifier: NCT02594345
• Other Study ID Numbers: ExoRBC
• First Posted: Nov 3, 2015
• Last Update Posted: Feb 23, 2016
• Last Verified: Feb 1, 2016

Study Results

No Results Posted as of Feb 23, 2016