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

Transfusion Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423135
• Other study ID #: Protocol 06/14
• Secondary ID: 12C14NL
• Status: Completed
• Phase: N/A
• First received: October 13, 2014
• Last updated: April 17, 2015
• Start date: October 2014
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Transfusion Reaction

Intervention

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

Locations

Country	Name	City	State
Switzerland	Swiss Laboratory for Doping Analyses	Epalinges	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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