Effect of Exosomes Derived From Red Blood Cell Units on P... | NCT02594345

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

NCT02594345

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Feb 23, 2016Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Blood Coagulation
Platelet Function

Interventions

in vitro study

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Oct 30, 2015

First Submission Date that Met QC Criteria

Oct 30, 2015

First Posted Date

Nov 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2016

Last Update Posted Date

Feb 23, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Dania Fischer, Research associate, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental		Other: in vitro study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
in vitro study	Other	Exosomes will be mixed with healthy volunteers' blood in vitro	Intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
clot formation	measured by thromboelastometry (ROTEM® Analysis)	1h after exposure
clot stability	measured by thromboelastometry (ROTEM® Analysis)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

pregnancy
drug use

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dania P Fischer, M.D.	Goethe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Frankfurt		Frankfurt am Main	Hesse	60590	Germany

Condition Browse Module

MeSH Terms

ID	Term
D013927	Thrombosis

Ancestor Terms

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided