Blood Donation With HemapheresisNCT01576237
Multinational Haemapheresis Vigilance Study
An observational study of Blood Donation With Hemapheresis, run by DGTI - Haemapheresis Vigilance Working Party.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Donation With Hemapheresis
- What is being tested?
- blood donation
- How many people
- 50,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all blood donors having an Adverse Event during preparative cell aphereses
Who may be able to join
- 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
Show all 9Show fewer
- platelet count >= 150 × 10e9/L for platelet apheresis
- blood volume of > 5 L for 2 unit red cell apheresis
- normal leukocyte count
Who cannot join
None listed.
About this study
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
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.
Read the 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.
- Conditions
- Blood Donation With Hemapheresis
- Being tested
- blood donation
- Keywords
- hemovigilance, hemapheresis, donor vigilance, plasmapheresis, platelet apheresis, leukapheresis, stem cell apheresis, granulocyte apheresis, monocyte apheresis, red cell apheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood donationOther
blood donation with preparative hemapheresis
| Study group | Role | What they receive |
|---|---|---|
| healthy apheresis donors | healthy blood donors for blood cell aphereses Receives: Other: blood donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to one year
Secondary outcomes (1)
Rate of products per apheresis
amount of obtained products vs. anticipated products
Measured: hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Donation With HemapheresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DGTI - Haemapheresis Vigilance Working Party
- Sponsor type
- Research network
- Collaborators
- Aix Scientifics
- Responsible party
- Sponsor
- Investigators
- Hans-Gert Heuft, PD. Dr. med., Principal investigator, Hannover Medical School (MHH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576237
- Sponsor's protocol ID
- DGTI-AGHV_01
- Status last verified
- Jul 2021
- First submitted
- 10 Apr 2012
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01576237
- Acronym / sponsor ID
- DGTI-AGHV_01
- Conditions
- Blood Donation With Hemapheresis
- Keywords
- hemovigilance, hemapheresis, donor vigilance, plasmapheresis, platelet apheresis, leukapheresis, stem cell apheresis, granulocyte apheresis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- DGTI - Haemapheresis Vigilance Working PartyResearch network
- Collaborators
- Aix Scientifics
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy apheresis donors | – | Other: blood donationhealthy blood donors for blood cell aphereses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all blood donors having an Adverse Event during preparative cell aphereses
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood donationblood donation with preparative hemapheresis | Other | healthy apheresis donors |
Primary outcome
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
1 secondary outcome
Rate of products per apheresis
Time frame: hemapheresis stay: expected time range from 1 hour for plasmaphereses to 5 hours for stem cell aphereses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- European Donor Haemovigilance system (EDoH)Link provided by the sponsor.
- European Donor Haemovigilance system (EDoH)Link provided by the sponsor.
Related trials for Blood Donation With Hemapheresis
RecruitingPhase 4
Improving White Blood Cell Collection From Healthy Donors
Allogeneic Granulocyte Donation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Gert Heuft, PD. Dr. med. principal investigator
Hannover Medical School (MHH)
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Donation With Hemapheresis, run by DGTI - Haemapheresis Vigilance Working Party.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of all non-trivial adverse events (AE) occurring during hemapheresis (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.