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

NCT ID: NCT02423135

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Transfusion Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Blood bags without DEHP

Intervention : Autologous blood transfusion

Group Type EXPERIMENTAL

Autologous blood transfusion

Intervention Type BIOLOGICAL

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

Blood bags with DEHP

Intervention : Autologous blood transfusion

Group Type EXPERIMENTAL

Autologous blood transfusion

Intervention Type BIOLOGICAL

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

Interventions

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Autologous blood transfusion

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Nicolas Leuenberger

Dr, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas Leuenberger, PhD

Role: PRINCIPAL_INVESTIGATOR

Swiss Laboratory for Doping Analyses

Locations

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Swiss Laboratory for Doping Analyses

Épalinges, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 26822428 (View on PubMed)

Other Identifiers

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12C14NL

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Protocol 06/14

Identifier Type: -

Identifier Source: org_study_id

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