Multinational Haemapheresis Vigilance Study

• Conditions: Blood Donation With Hemapheresis
• Interventions: Other: blood donation

• Registration Number: NCT01576237
• Lead Sponsor: DGTI - Haemapheresis Vigilance Working Party

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy apheresis donors	blood donation	healthy blood donors for blood cell aphereses

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of products per apheresis	hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses	amount of obtained products vs. anticipated products