Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion in Anti-doping

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Completed

CT.gov ID

NCT02423135

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the proposed project is to perform a clinical study in which volunteers will receive autologous blood transfusions in DEHP-free blood bags.

Condition or Disease	Intervention/Treatment	Phase
Transfusion Reaction	Biological: Autologous blood transfusion	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

Official Title:

Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion Using a Combination of Multiple Biomarkers in Different Matrices.

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Blood bags without DEHP Intervention : Autologous blood transfusion	Biological: Autologous blood transfusion Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.
Experimental: Blood bags with DEHP Intervention : Autologous blood transfusion	Biological: Autologous blood transfusion Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.

Arm

Intervention/Treatment

Experimental: Blood bags without DEHP

Intervention : Autologous blood transfusion

Biological: Autologous blood transfusion

Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.

Experimental: Blood bags with DEHP

Intervention : Autologous blood transfusion

Biological: Autologous blood transfusion

Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.

Outcome Measures

Primary Outcome Measures

Measurement of blood parameters profile, iron metabolism and genomic compounds [1 month]
Blood profiling such as measurement of concentration of different blood cells and hemoglobin will be measured up to 15 days after blood-reinfusion. Concentration of free-iron, ferritin and hepcidin will be measured in plasma and serum up to 15 days after blood re-infusion. Concentration of circulating microRNAs will be measured in plasma also up to 15 days after blood re-infusion. All measures are compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Have to fill the swiss blood donation formulary

Exclusion Criteria:

Anemia
Cardiovascular disease
Neurologic disease
Not performed a blood donation for 5 weeks ago the start of the study.
Immunological disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Swiss Laboratory for Doping Analyses	Epalinges	Vaud	Switzerland	1066

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators

Principal Investigator: Nicolas Leuenberger, PhD, Swiss Laboratory for Doping Analyses

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nicolas Leuenberger, Dr, PhD, Centre Hospitalier Universitaire Vaudois

ClinicalTrials.gov Identifier:

NCT02423135

Other Study ID Numbers:

Protocol 06/14
12C14NL

First Posted:

Apr 22, 2015

Last Update Posted:

Apr 22, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Transfusion Reaction

Study Results

No Results Posted as of Apr 22, 2015