Clinical trial NCT01576237: Multinational Haemapheresis Vigilance Study
Official title: Open Prospective Multi-national Long-term Study to Register Adverse Events Related to Hemaphereses by Means of an Internet-based Haemapheresis Vigilance Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Donation With Hemapheresis
Keywords: hemovigilance
hemapheresis
donor vigilance
plasmapheresis
platelet apheresis
leukapheresis
stem cell apheresis
granulocyte apheresis
monocyte apheresis
red cell apheresis
Lead sponsor: DGTI - Haemapheresis Vigilance Working Party
Sponsor class: NETWORK
Collaborators: name: Aix Scientifics
First posted: 2012-04-12
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all blood donors having an Adverse Event during preparative cell aphereses

Brief summary: During a seven years period the participating transfusion medicine establishments will report all their non-trivial adverse events (AE) occurring during preparative hemaphereses. Complications may be related to the blood donors, the blood products, the disposables or the apheresis devices. The study hypothesis regarding each participating center is that their procedure-related AE rate is not higher than the respective rate of all other centers in total.

Detailed description: In the scope of this study the participating transfusion medicine establishments obligate themselves to record all significant Adverse Events (AE) related to preparative hemaphereses of healthy donors. All complications (phlebotomy and circulation problems, citrate toxicity, donor compliance, and technical complications) shall be assessed with respect to plasma-, platelet-, leukocyte- (stem cells, granulocytes, monocytes), and red cell aphereses as well as multicomponent aphereses. Study data are recorded by means of an Internet-based hemapheresis vigilance system. Study results will be evaluated according to the advanced standards of the International Haemovigilance Network (IHN). The study contributes to the quality assurance of each single center as it enables the comparison to other transfusion medicine establishments.

Eligibility criteria: Inclusion Criteria:

* blood donor standard criteria :
* healthy donor of \> 50 kg
* hemoglobin 125 g/L or 7.8 mmol/L (female donors)
* hemoglobin 135 g/L or 8.4 mmol/L (male donors)
* hemoglobin \> 140 g/L for 2 unit red cell apheresis
* total proteins \>= 60 g/L for plasmapheresis
* platelet count \>= 150 × 10e9/L for platelet apheresis
* blood volume of \> 5 L for 2 unit red cell apheresis
* normal leukocyte count

Primary outcomes:
measure: Assessment of all non-trivial adverse events (AE) occurring during hemapheresis
timeFrame: up to one year
Secondary outcomes:
measure: Rate of products per apheresis
timeFrame: hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses
Other outcomes:
Locations:
Study officials:
affiliation: Hannover Medical School (MHH)
name: Hans-Gert Heuft, PD. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: