Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion in Anti-doping
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 22, 2015
CompletedApril 22, 2015
April 1, 2015
3 months
October 13, 2014
April 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 month
Study Arms (2)
Blood bags without DEHP
EXPERIMENTALIntervention : Autologous blood transfusion
Blood bags with DEHP
EXPERIMENTALIntervention : Autologous blood transfusion
Interventions
Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.
Eligibility Criteria
You may qualify if:
- Have to fill the swiss blood donation formulary
You may not qualify if:
- Anemia
- Cardiovascular disease
- Neurologic disease
- Not performed a blood donation for 5 weeks ago the start of the study.
- Immunological disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swiss Laboratory for Doping Analyses
Épalinges, Canton of Vaud, 1066, Switzerland
Related Publications (1)
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.
PMID: 26822428DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas Leuenberger, PhD
Swiss Laboratory for Doping Analyses
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr, PhD
Study Record Dates
First Submitted
October 13, 2014
First Posted
April 22, 2015
Study Start
October 1, 2014
Primary Completion
January 1, 2015
Study Completion
February 1, 2015
Last Updated
April 22, 2015
Record last verified: 2015-04