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Multinational Haemapheresis Vigilance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01576237
Recruitment Status : Active, not recruiting
First Posted : April 12, 2012
Last Update Posted : July 22, 2021
Sponsor:
Collaborator:
Aix Scientifics
Information provided by (Responsible Party):
DGTI - Haemapheresis Vigilance Working Party

Study Description
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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.

Condition or disease Intervention/treatment
Blood Donation With Hemapheresis Other: blood donation

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 Design
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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Other
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
Actual Study Start Date : February 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
healthy apheresis donors
healthy blood donors for blood cell aphereses
 Other: blood donation
blood donation with preparative hemapheresis


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of all non-trivial adverse events (AE) occurring during hemapheresis [ Time Frame: up to one year ]
    All non-trivial AEs will be recorded regardless of whether anticipated products have been collected or not


Secondary Outcome Measures :
  1. Rate of products per apheresis [ Time Frame: hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses ]
    amount of obtained products vs. anticipated products


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
all blood donors having an Adverse Event during preparative cell aphereses
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576237


Sponsors and Collaborators
DGTI - Haemapheresis Vigilance Working Party
Aix Scientifics
Investigators
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Principal Investigator: Hans-Gert Heuft, PD. Dr. med. Hannover Medical School (MHH)
More Information
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Additional Information:

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Responsible Party: DGTI - Haemapheresis Vigilance Working Party
ClinicalTrials.gov Identifier: NCT01576237    
Other Study ID Numbers: DGTI-AGHV_01
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
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