NCT01576237

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

10.8 years

First QC Date

April 10, 2012

Last Update Submit

July 21, 2021

Conditions

Blood Donation With Hemapheresis

Keywords

hemovigilancehemapheresisdonor vigilanceplasmapheresisplatelet apheresisleukapheresisstem cell apheresisgranulocyte apheresismonocyte apheresisred cell apheresis

Outcome Measures

Primary Outcomes (1)

  • Assessment of all non-trivial adverse events (AE) occurring during hemapheresis

    All non-trivial AEs will be recorded regardless of whether anticipated products have been collected or not

    up to one year

Secondary Outcomes (1)

  • Rate of products per apheresis

    hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses

Study Arms (1)

healthy apheresis donors

healthy blood donors for blood cell aphereses

Other: blood donation

Interventions

blood donationOTHER

blood donation with preparative hemapheresis

healthy apheresis donors

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all blood donors having an Adverse Event during preparative cell aphereses

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Blood Donation

Intervention Hierarchy (Ancestors)

Tissue and Organ ProcurementHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hans-Gert Heuft, PD. Dr. med.

    Hannover Medical School (MHH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 12, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

July 22, 2021

Record last verified: 2021-07