Blood DiseaseNCT00005341
Blood Donation--Immune Sequelae and Recruitment
An observational study of Blood Disease and Blood Donors, run by University of New Mexico.
Trial summary
To determine if there were immune sequelae related to the long-term donation of blood or blood products. Read more about this study
- Who is it for?
- Ages 0 to 100 years, men only
- Conditions the study is for
- Blood Disease, Blood Donors
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 1992to Jan 1997
- 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 0 to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine if there were immune sequelae related to the long-term donation of blood or blood products.
Read the detailed description
DESIGN NARRATIVE:
The study had two objectives. The first objective was to investigate changes in immune function which may have occurred as a result of blood, plasma, or platelet donations. Preliminary studies had shown evidence of alterations in immune parameters in normal apheresis donors with the most marked changes occurring in long-term plasmapheresis donors. To ascertain whether donation of blood or blood products altered specific immune parameters, studies were conducted on white blood cell (WBC) receptors known to be involved in normal host defense mechanisms, lymphocyte subpopulations, plasma proteins, and complement activation products from 30 individuals in each of four separate donor groups: whole blood donors, bulk plasma donors, plasma donors stimulated with incompatible RBC, and platelet donors. Donor immune data were compared with results in nondonor controls and were also correlated with demographic data, donation history, laboratory data, and clinical findings. The second objective of the study was to determine if changes in an individual donor's immune status occurred over time. A longitudinal study of 15 new donors in each donation group was performed to evaluate alterations in immune function that may have occurred in committed donors of blood products and whether there was any clinical significance to the findings. New donors were enrolled in donation groups and followed longitudinally for a period of up to two years.
The study was extended through January, 1997 on FY 1995 funds.
- Conditions
- Blood Disease, Blood Donors
- Medical subject headings
- Hematologic Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startFeb 1992
- Study completionJan 1997
Why it stopped: Not a clinical trial and was inadvertently entered in the system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood DiseaseStudies 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
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005341
- Sponsor's protocol ID
- 4204
- Other IDs
- R01HL045642
- Status last verified
- Mar 2024
- First submitted
- 25 May 2000
- Last updated
- 12 Mar 2024
- Results posted
- No
Publications
Kutvirt SG, Armon ME, Simon TL, Lewis SL. Lymphocyte phenotypes and infection incidence in transfused preterm neonates. Transfus Med. 1996 Dec;6(4):329-36. doi: 10.1111/j.1365-3148.1996.tb00092.x.
PubMed 8981728
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Donation--Immune Sequelae and Recruitment
- ClinicalTrials.gov ID
- NCT00005341
- Acronym / sponsor ID
- 4204
- Conditions
- Blood Disease, Blood Donors
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not a clinical trial and was inadvertently entered in the system.
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 1992
- Study completion
- Jan 1997
- First posted
- 26 May 2000 (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.
To determine if there were immune sequelae related to the long-term donation of blood or blood products.
Detailed description
DESIGN NARRATIVE:
The study had two objectives. The first objective was to investigate changes in immune function which may have occurred as a result of blood, plasma, or platelet donations. Preliminary studies had shown evidence of alterations in immune parameters in normal apheresis donors with the most marked changes occurring in long-term plasmapheresis donors. To ascertain whether donation of blood or blood products altered specific immune parameters, studies were conducted on white blood cell (WBC) receptors known to be involved in normal host defense mechanisms, lymphocyte subpopulations, plasma proteins, and complement activation products from 30 individuals in each of four separate donor groups: whole blood donors, bulk plasma donors, plasma donors stimulated with incompatible RBC, and platelet donors. Donor immune data were compared with results in nondonor controls and were also correlated with demographic data, donation history, laboratory data, and clinical findings. The second objective of the study was to determine if changes in an individual donor's immune status occurred over time. A longitudinal study of 15 new donors in each donation group was performed to evaluate alterations in immune function that may have occurred in committed donors of blood products and whether there was any clinical significance to the findings. New donors were enrolled in donation groups and followed longitudinally for a period of up to two years.
The study was extended through January, 1997 on FY 1995 funds.
Study design
Who may qualify
- Ages
- 0 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Not a clinical trial and was inadvertently entered in the system.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 8981728Kutvirt SG, Armon ME, Simon TL, Lewis SL. Lymphocyte phenotypes and infection incidence in transfused preterm neonates. Transfus Med. 1996 Dec;6(4):329-36. doi: 10.1111/j.1365-3148.1996.tb00092.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Disease and Blood Donors, run by University of New Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 12 Mar 2024. 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?
The study was stopped early (reason given: Not a clinical trial and was inadvertently entered in the system.). 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005341, which also lists 1 linked publication.
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 12 Mar 2024.