Multinational Haemapheresis Vigilance Study
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Purpose
During a five 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.
| Condition | Intervention |
|---|---|
|
Blood Donation With Hemapheresis |
Other: blood donation |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
- Assessment of all non-trivial adverse events (AE) occurring during hemapheresis [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]All non-trivial AEs will be recorded regardless of whether anticipated products have been collected or not
- Rate of products per apheresis [ Time Frame: hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses ] [ Designated as safety issue: No ]amount of obtained products vs. anticipated products
| Estimated Enrollment: | 50000 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| healthy apheresis donors |
Other: blood donation
blood donation with preparative hemapheresis
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
all blood donors having an Adverse Event during preparative cell aphereses
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | DGTI - Haemapheresis Vigilance Working Party |
| ClinicalTrials.gov Identifier: | NCT01576237 History of Changes |
| Other Study ID Numbers: | DGTI-AGHV_01 |
| Study First Received: | April 10, 2012 |
| Last Updated: | April 11, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut Germany: Federal Institute for Drugs and Medical Devices Austria: Federal Office for Safety in Health Care Switzerland: Swissmedic |
Keywords provided by DGTI - Haemapheresis Vigilance Working Party:
|
hemovigilance hemapheresis donor vigilance plasmapheresis platelet apheresis |
leukapheresis stem cell apheresis granulocyte apheresis monocyte apheresis red cell apheresis |
ClinicalTrials.gov processed this record on June 18, 2013