NCT03548766

Brief Summary

A total of 12 subjects will be recruited for participation in this study. 6 subjects will receive re-infusion of autologous blood, and 6 subjects (anemic patients) will receive a homologous transfusion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

3.2 years

First QC Date

May 6, 2018

Last Update Submit

August 9, 2020

Conditions

Blood DiseaseBlood Transfusion, AutologousBlood DopingBlood Transfusion, Homologous

Outcome Measures

Primary Outcomes (2)

  • Donor DNA (# of loci with triplets or quadruplets):

    Clearance Kinetics of donor DNA which is transferred during the transfusion of one bag of homologous blood will be established.

    12 months

  • Cellular Microparticles (10^3/uL):

    Clearance Kinetics of cellular microparticles which are introduced during an autologous blood transfusion and are originating from red blood cells during blood storage will be established.

    12 months

Study Arms (2)

Healthy Subjects

EXPERIMENTAL

Six healthy subjects will receive an ABT (Autologous Blood Transfusion)

Biological: Autologous Blood Transfusion

Anemic Patients

EXPERIMENTAL

Six patients with anemia will receive a HBT (Homologous Blood Transfusion)

Biological: Homologous Blood Transfusion

Interventions

Homologous Blood TransfusionBIOLOGICAL

Homologous, or allogenic, blood transfusions involves someone collecting and infusing the blood of a compatible donor into him/herself.

Also known as: Allogenic Blood Transfusion
Anemic Patients
Autologous Blood TransfusionBIOLOGICAL

Autologous blood transfusion is the collection and re-infusion of the patient's own blood or blood components.

Healthy Subjects

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • both genders,
  • age 20-50 years and
  • preferably physically active but no elite athletes subjected to Anti-Doping testing.

You may not qualify if:

  • vulnerable subjects
  • not willing to participate
  • not signing the ICF
  • patients with end-organ failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

RECRUITING

Related Publications (15)

  • Voss SC, Thevis M, Schinkothe T, Schanzer W. Detection of homologous blood transfusion. Int J Sports Med. 2007 Aug;28(8):633-7. doi: 10.1055/s-2007-965076. Epub 2007 Jul 5.

    PMID: 17614019BACKGROUND

  • Giraud S, Robinson N, Mangin P, Saugy M. Scientific and forensic standards for homologous blood transfusion anti-doping analyses. Forensic Sci Int. 2008 Jul 18;179(1):23-33. doi: 10.1016/j.forsciint.2008.04.007. Epub 2008 Jun 2.

    PMID: 18514452BACKGROUND

  • Krotov G, Nikitina M, Rodchenkov G. Possible cause of lack of positive samples on homologous blood transfusion. Drug Test Anal. 2014 Nov-Dec;6(11-12):1160-2. doi: 10.1002/dta.1736. Epub 2014 Oct 20.

    PMID: 25331764BACKGROUND

  • Donati F, Stampella A, de la Torre X, Botre F. Investigation on the application of DNA forensic human identification techniques to detect homologous blood transfusions in doping control. Talanta. 2013 Jun 15;110:28-31. doi: 10.1016/j.talanta.2013.02.042. Epub 2013 Mar 18.

    PMID: 23618171BACKGROUND

  • Stampella A, Di Marco S, Pirri D, de la Torre X, Botre F, Donati F. Application of DNA-based forensic analysis for the detection of homologous transfusion of whole blood and of red blood cell concentrates in doping control. Forensic Sci Int. 2016 Aug;265:204-10. doi: 10.1016/j.forsciint.2016.04.021. Epub 2016 Apr 30.

    PMID: 27175858BACKGROUND

  • Manokhina I, Rupert JL. A DNA-based method for detecting homologous blood doping. Anal Bioanal Chem. 2013 Dec;405(30):9693-701. doi: 10.1007/s00216-013-7122-8. Epub 2013 Jul 11.

    PMID: 23842898BACKGROUND

  • Alizadeh M, Bernard M, Danic B, Dauriac C, Birebent B, Lapart C, Lamy T, Le Prise PY, Beauplet A, Bories D, Semana G, Quelvennec E. Quantitative assessment of hematopoietic chimerism after bone marrow transplantation by real-time quantitative polymerase chain reaction. Blood. 2002 Jun 15;99(12):4618-25. doi: 10.1182/blood.v99.12.4618.

    PMID: 12036896BACKGROUND

  • Ni W, Le Guiner C, Moullier P, Snyder RO. Development and utility of an internal threshold control (ITC) real-time PCR assay for exogenous DNA detection. PLoS One. 2012;7(5):e36461. doi: 10.1371/journal.pone.0036461. Epub 2012 May 3.

    PMID: 22570718BACKGROUND

  • Almizraq RJ, Seghatchian J, Acker JP. Extracellular vesicles in transfusion-related immunomodulation and the role of blood component manufacturing. Transfus Apher Sci. 2016 Dec;55(3):281-291. doi: 10.1016/j.transci.2016.10.018. Epub 2016 Oct 28.

    PMID: 27865649BACKGROUND

  • Straat M, Boing AN, Tuip-De Boer A, Nieuwland R, Juffermans NP. Extracellular Vesicles from Red Blood Cell Products Induce a Strong Pro-Inflammatory Host Response, Dependent on Both Numbers and Storage Duration. Transfus Med Hemother. 2016 Jul;43(4):302-305. doi: 10.1159/000442681. Epub 2015 Dec 16.

    PMID: 27721707BACKGROUND

  • van der Pol E, Coumans FA, Grootemaat AE, Gardiner C, Sargent IL, Harrison P, Sturk A, van Leeuwen TG, Nieuwland R. Particle size distribution of exosomes and microvesicles determined by transmission electron microscopy, flow cytometry, nanoparticle tracking analysis, and resistive pulse sensing. J Thromb Haemost. 2014 Jul;12(7):1182-92. doi: 10.1111/jth.12602. Epub 2014 Jun 19.

    PMID: 24818656BACKGROUND

  • Nielsen MH, Beck-Nielsen H, Andersen MN, Handberg A. A flow cytometric method for characterization of circulating cell-derived microparticles in plasma. J Extracell Vesicles. 2014 Feb 4;3. doi: 10.3402/jev.v3.20795. eCollection 2014.

    PMID: 24511371BACKGROUND

  • Rubin O, Crettaz D, Tissot JD, Lion N. Pre-analytical and methodological challenges in red blood cell microparticle proteomics. Talanta. 2010 Jun 30;82(1):1-8. doi: 10.1016/j.talanta.2010.04.025. Epub 2010 Apr 22.

    PMID: 20685428BACKGROUND

  • Rank A, Nieuwland R, Crispin A, Grutzner S, Iberer M, Toth B, Pihusch R. Clearance of platelet microparticles in vivo. Platelets. 2011;22(2):111-6. doi: 10.3109/09537104.2010.520373. Epub 2011 Jan 13.

    PMID: 21231854BACKGROUND

  • Voss SC, Jaganjac M, Al-Thani AM, Grivel JC, Raynaud CM, Al-Jaber H, Al-Menhali AS, Merenkov ZA, Alsayrafi M, Latiff A, Georgakopoulos C. Analysis of RBC-microparticles in stored whole blood bags - a promising marker to detect blood doping in sports? Drug Test Anal. 2017 Nov;9(11-12):1794-1798. doi: 10.1002/dta.2212. Epub 2017 Jun 20.

    PMID: 28474406BACKGROUND

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Blood Transfusion, Autologous

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeutics

Study Officials

  • Sven Voss

    ADLQ

    STUDY CHAIR

  • Mohamed Yassin

    Hamad Medical Corporation

    PRINCIPAL INVESTIGATOR

  • Francesco Donati

    Laboratorio Antidoping FMSI, Rome, Italy

    PRINCIPAL INVESTIGATOR

  • Costas Georgakopoulos

    ADLQ

    PRINCIPAL INVESTIGATOR

  • Mohammed Alsayrafi

    ADLQ

    PRINCIPAL INVESTIGATOR

  • Jean-Charles Grivel

    Sidra Medicine

    PRINCIPAL INVESTIGATOR

  • Christophe Raynaud

    Sidra Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven C Voss

CONTACT

0097455481955svoss@adlqatar.qa

Abdulqadir Nashwan

CONTACT

0097466473549anashwan@hamad.qa

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hematology Consultant

Study Record Dates

First Submitted

May 6, 2018

First Posted

June 7, 2018

Study Start

September 20, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 11, 2020

Record last verified: 2020-08

Locations

QA(1)