Multinational Haemapheresis Vigilance Study

DGTI - Haemapheresis Vigilance Working Party

Status: Unknown

Conditions: Blood Donation With Hemapheresis

Treatments: Other: blood donation

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT01576237

DGTI-AGHV_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

50,000 participants in 1 patient group

healthy apheresis donors

Description:

healthy blood donors for blood cell aphereses

Treatment:

Other: blood donation