Multinational Haemapheresis Vigilance Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2022-12-31

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.

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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.

Conditions

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Blood Donation With Hemapheresis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy apheresis donors

healthy blood donors for blood cell aphereses

blood donation

Intervention Type OTHER

blood donation with preparative hemapheresis

Interventions

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blood donation

blood donation with preparative hemapheresis

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes