Multinational Haemapheresis Vigilance Study

July 21, 2021 updated by: DGTI - Haemapheresis Vigilance Working Party

Open Prospective Multi-national Long-term Study to Register Adverse Events Related to Hemaphereses by Means of an Internet-based Haemapheresis Vigilance Questionnaire

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all blood donors having an Adverse Event during preparative cell aphereses

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy apheresis donors
healthy blood donors for blood cell aphereses
Other: blood donation
blood donation with preparative hemapheresis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DGTI - Haemapheresis Vigilance Working Party

Collaborators

Aix Scientifics

Investigators

  • Principal Investigator: Hans-Gert Heuft, PD. Dr. med., Hannover Medical School (MHH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

April 10, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (ESTIMATE)

April 12, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DGTI-AGHV_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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