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Multinational Haemapheresis Vigilance Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Aix Scientifics
Information provided by (Responsible Party):
DGTI - Haemapheresis Vigilance Working Party
ClinicalTrials.gov Identifier:
NCT01576237
First received: April 10, 2012
Last updated: April 11, 2012
Last verified: April 2012
  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

Further study details as provided by DGTI - Haemapheresis Vigilance Working Party:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576237

Sponsors and Collaborators
DGTI - Haemapheresis Vigilance Working Party
Aix Scientifics
Investigators
Principal Investigator: Hans-Gert Heuft, PD. Dr. med. Hannover Medical School (MHH)
  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 November 24, 2014