Multinational Haemapheresis Vigilance Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Open Prospective Multi-national Long-term Study to Register Adverse Events Related to Hemaphereses by Means of an Internet-based Haemapheresis Vigilance Questionnaire

Conditions
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Blood Donation With Hemapheresis

Intervention / Treatment
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* Other: blood donation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy apheresis donors<br>healthy blood donors for blood cell aphereses | Other: blood donation<br>* blood donation with preparative hemapheresis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of all non-trivial adverse events (AE) occurring during hemapheresis | All non-trivial AEs will be recorded regardless of whether anticipated products have been collected or not | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of products per apheresis | amount of obtained products vs. anticipated products | hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemovigilance, hemapheresis, donor vigilance, plasmapheresis, platelet apheresis, leukapheresis, stem cell apheresis, granulocyte apheresis, monocyte apheresis, red cell apheresis