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

Primary Purpose

Transfusion Reaction

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Autologous blood transfusion
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Transfusion Reaction

Eligibility Criteria

20 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Swiss Laboratory for Doping Analyses

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Blood bags without DEHP

Blood bags with DEHP

Arm Description

Intervention : Autologous blood transfusion

Intervention : Autologous blood transfusion

Outcomes

Primary Outcome Measures

Measurement of blood parameters profile, iron metabolism and genomic compounds
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.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2014
Last Updated
April 17, 2015
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT02423135
Brief Title
Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion in Anti-doping
Official Title
Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion Using a Combination of Multiple Biomarkers in Different Matrices.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transfusion Reaction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood bags without DEHP
Arm Type
Experimental
Arm Description
Intervention : Autologous blood transfusion
Arm Title
Blood bags with DEHP
Arm Type
Experimental
Arm Description
Intervention : Autologous blood transfusion
Intervention Type
Biological
Intervention Name(s)
Autologous blood transfusion
Intervention Description
Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.
Primary Outcome Measure Information:
Title
Measurement of blood parameters profile, iron metabolism and genomic compounds
Description
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.
Time Frame
1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Leuenberger, PhD
Organizational Affiliation
Swiss Laboratory for Doping Analyses
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Laboratory for Doping Analyses
City
Epalinges
State/Province
Vaud
ZIP/Postal Code
1066
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26822428
Citation
Leuenberger N, Barras L, Nicoli R, Robinson N, Baume N, Lion N, Barelli S, Tissot JD, Saugy M. Hepcidin as a new biomarker for detecting autologous blood transfusion. Am J Hematol. 2016 May;91(5):467-72. doi: 10.1002/ajh.24313. Epub 2016 Apr 6.
Results Reference
derived

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

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