MedDRA - 10024922: low platelets Pathogen inactivation of platelet concentrates D69.6
Conditions
Interventions
Group 1: In total 3 series of autologous transfusion of autologous single UVC-treated platelet concentrate (PC) will be performed. In the first series, participants will be treated with increasing par
1/4
1/2) of a single PC (approx. 350mL) at intervals of 30 min. In the second series a full PC and in the third PC double PC (approx. 700 mL) will be transfused. Time interval between each series will be
Sponsors
Blutspendedienst der Landesverbände des Deutschen Roten Kreuzes Niedersachsen, Sachsen-Anhalt, Thüringen, Oldenburg und Bremen gGmbH (DRK-BSD NSTOB)
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Healthy according to medical history, physical examination, and laboratory testing, as laid down in the German Haemotherapy Guidelines for allogeneic blood donation, including suitability of veins for apheresis procedures 2. Suitability of subjects to undergo double apheresis procedures 3. Aged 18 up to and including 40 years 4. Male 5. Oral and written information to the subjects on the clinical trial and written informed consent maximally one week and at least 1 day before start of first apheresis procedure
Exclusion criteria
Exclusion criteria: 1. Participation in a clinical trial of medicinal products within the preceding 3 months (i.e. 90 days). 2. Intended surgeries or dental surgery within the next 6 months (i.e. 180 days). 3. Acute or history of allergic reactions to components of PCs. 4. Known presence of refractoriness to PCs 5. Drug abuse (including alcohol misuse, checked by use of the routine blood donor questionnaire). 6. Legal incapacity or other circumstances preventing the volunteer from understanding the nature, meaning and implications of the clinical trial. 7. History of abnormal bleeding, thrombosis or thrombophilic diathesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is the demonstration of safety and tolerance of the administration of autologous UVC-treated PCs stored for 2+ days before administration as assessed by measuring the parameters platelet count, Quick value, activated partial thromboplastine time (aPPT), fibrinogen and D-dimers | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are the assessments of further safety variables (blood pressure, pulse rate, signs and symptoms) and the determination of CCIs at 1 and 24 hours after administration of full doses of autologous UVC-treated PCs stored for 2+ and of full and double doses of autologous UVC-treated PCs stored for 2+ days before administration | — |
Countries
Germany
Contacts
Public ContactThomas Thiele
Abteilung Transfusionsmedizin, Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts
Outcome results
None listed