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Tolerance of platelet concentrates treated with UVC-light only for pathogen reduction--a phase I clinical trial.
- Source :
-
Vox sanguinis [Vox Sang] 2015 Jul; Vol. 109 (1), pp. 44-51. Date of Electronic Publication: 2015 Mar 06. - Publication Year :
- 2015
-
Abstract
- Background: The THERAFLEX UV-Platelets pathogen reduction system for platelet concentrates (PCs) operates with ultraviolet C light (UVC; 254 nm) only without addition of photosensitizers. This phase I study evaluated safety and tolerability of autologous UVC-irradiated PCs in healthy volunteers.<br />Methods: Eleven volunteers underwent two single (series 1 and 2) and one double apheresis (series 3). PCs were treated with UVC, stored for 48 h and retransfused in a dose-escalation scheme: 12·5, 25% and 50% of a PC (series 1); one complete PC (series 2); two PCs (series 3). Platelet counts, fibrinogen, activated partial thromboplastin time, prothrombin time, D-dimer, standard haematology, temperature, heart rate, blood pressure and clinical chemistry parameters were measured. One- and 24-h corrected count increments were determined in series 2 and 3. Platelet-specific antibodies were assessed before and at the end of the study.<br />Results: Neither adverse reactions related to transfusions nor antibodies against UVC-treated platelets were observed. Corrected count increments did not differ between series 2 and 3.<br />Conclusions: Repeated transfusions of autologous UVC-treated PCs were well tolerated and did not induce antibody responses in all volunteers studied. EudraCT No. 2010-023404-26.<br /> (© 2015 International Society of Blood Transfusion.)
- Subjects :
- Adult
Blood Platelets drug effects
Fibrin Fibrinogen Degradation Products analysis
Healthy Volunteers
Humans
Immunoglobulin E blood
Male
Partial Thromboplastin Time
Photosensitizing Agents pharmacology
Platelet Count
Prothrombin Time
Young Adult
Blood Platelets radiation effects
Platelet Transfusion adverse effects
Ultraviolet Rays
Subjects
Details
- Language :
- English
- ISSN :
- 1423-0410
- Volume :
- 109
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Vox sanguinis
- Publication Type :
- Academic Journal
- Accession number :
- 25754418
- Full Text :
- https://doi.org/10.1111/vox.12247