HealthyNCT00460122
Effects of Antibodies to White Blood Cells on Platelet Transfusion Patients
An observational study of Healthy and Transfusion Reactions, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will determine if transfusion of platelets containing HLA antibodies (certain antibodies to white blood cells) are more likely to cause transfusion reactions than transfusion of platelets that do not contain HLA antibodies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy, Transfusion Reactions
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2007to 10 Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female donors
- Any ethnic group
- 18 years of age or older
- Must meet the criteria for donating platelets in the DTM
Who cannot join
- 1. Donors are not eligible to donate platelets in the DTM
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pilot Study of the Incidence of HLA Class I and Class II Antibodies in Platelet Donors and Their Effects on the Transfusion Recipient
This study will determine if transfusion of platelets containing HLA antibodies (certain antibodies to white blood cells) are more likely to cause transfusion reactions than transfusion of platelets that do not contain HLA antibodies.
People 18 years of age or older who donate platelets at the NIH Clinical Center may be eligible for this study.
An extra tube of blood (about one teaspoon) is obtained from participating donors at the time of their donation at the NIH Platelet Center. The blood plasma in the extra tube is tested for HLA antibodies and antibodies to certain white blood cells called granulocytes. The research sample is assigned a code number for identification and sent to the HLA Laboratory in the Department of Transfusion Medicine.
Read the detailed description
Leukocyte antibodies can cause febrile transfusion reactions, pulmonary reactions to granulocyte transfusions, and transfusion related acute lung injury (TRALI). Despite the fact that the role of leukocyte antibodies in these reactions was first described almost 50 years ago, and that TRALI is now the leading cause of transfusion related fatalities, much remains uncertain concerning the role of HLA antibodies in these reactions. The primary purpose of this study is to retrospectively and prospectively determine if the incidence and nature of transfusion reactions differs in Clinical Center (CC) patients that were transfused with platelet components from donors with HLA antibodies and those without HLA antibodies. In addition, this study will prospectively determine the incidence of HLA antibodies in the NIH Department of Transfusion Medicine (DTM) platelet donor population. In this natural history study a 10-mL blood sample will be drawn from 600 platelet donors at the time that they are in the DTM donating platelets and it will be tested for HLA antibodies in the DTM. The blood sample for HLA antibody testing will be collected with other samples collected as part of the regular platelet donation process. Reactions in platelet transfusion recipients will be assessed by reviewing CC and DTM patient records.
- Conditions
- Healthy, Transfusion Reactions
- Keywords
- Human Leukocyte Antigens (HLA), Transfusion Reactions, Platelet Donors
- Medical subject headings
- Transfusion Reaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study start10 Apr 2007
- Study completion10 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Time perspective
- Other
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Investigators
- David F Stroncek, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460122
- Sponsor's protocol ID
- 070125
- Other IDs
- 07-CC-0125
- Status last verified
- 10 Aug 2012
- First submitted
- 12 Apr 2007
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Toy P, Popovsky MA, Abraham E, Ambruso DR, Holness LG, Kopko PM, McFarland JG, Nathens AB, Silliman CC, Stroncek D; National Heart, Lung and Blood Institute Working Group on TRALI. Transfusion-related acute lung injury: definition and review. Crit Care Med. 2005 Apr;33(4):721-6. doi: 10.1097/01.ccm.0000159849.94750.51.
PubMed 15818095Goldman M, Webert KE, Arnold DM, Freedman J, Hannon J, Blajchman MA; TRALI Consensus Panel. Proceedings of a consensus conference: towards an understanding of TRALI. Transfus Med Rev. 2005 Jan;19(1):2-31. doi: 10.1016/j.tmrv.2004.10.001.
PubMed 15830325BRITTINGHAM TE. Immunologic studies on leukocytes. Vox Sang. 1957 Sep;2(4):242-8. doi: 10.1111/j.1423-0410.1957.tb03699.x. No abstract available.
PubMed 13496693
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Incidence of HLA Class I and Class II Antibodies in Platelet Donors and Their Effects on the Transfusion Recipient
- ClinicalTrials.gov ID
- NCT00460122
- Acronym / sponsor ID
- 070125
- Conditions
- Healthy, Transfusion Reactions
- Keywords
- Human Leukocyte Antigens (HLA), Transfusion Reactions, Platelet Donors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 10 Apr 2007
- Study completion
- 10 Aug 2012
- First posted
- 13 Apr 2007 (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.
This study will determine if transfusion of platelets containing HLA antibodies (certain antibodies to white blood cells) are more likely to cause transfusion reactions than transfusion of platelets that do not contain HLA antibodies.
People 18 years of age or older who donate platelets at the NIH Clinical Center may be eligible for this study.
An extra tube of blood (about one teaspoon) is obtained from participating donors at the time of their donation at the NIH Platelet Center. The blood plasma in the extra tube is tested for HLA antibodies and antibodies to certain white blood cells called granulocytes. The research sample is assigned a code number for identification and sent to the HLA Laboratory in the Department of Transfusion Medicine.
Detailed description
Leukocyte antibodies can cause febrile transfusion reactions, pulmonary reactions to granulocyte transfusions, and transfusion related acute lung injury (TRALI). Despite the fact that the role of leukocyte antibodies in these reactions was first described almost 50 years ago, and that TRALI is now the leading cause of transfusion related fatalities, much remains uncertain concerning the role of HLA antibodies in these reactions. The primary purpose of this study is to retrospectively and prospectively determine if the incidence and nature of transfusion reactions differs in Clinical Center (CC) patients that were transfused with platelet components from donors with HLA antibodies and those without HLA antibodies. In addition, this study will prospectively determine the incidence of HLA antibodies in the NIH Department of Transfusion Medicine (DTM) platelet donor population. In this natural history study a 10-mL blood sample will be drawn from 600 platelet donors at the time that they are in the DTM donating platelets and it will be tested for HLA antibodies in the DTM. The blood sample for HLA antibody testing will be collected with other samples collected as part of the regular platelet donation process. Reactions in platelet transfusion recipients will be assessed by reviewing CC and DTM patient records.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (1 listed)
- 1. Donors are not eligible to donate platelets in the DTM
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 15818095Toy P, Popovsky MA, Abraham E, Ambruso DR, Holness LG, Kopko PM, McFarland JG, Nathens AB, Silliman CC, Stroncek D; National Heart, Lung and Blood Institute Working Group on TRALI. Transfusion-related acute lung injury: definition and review. Crit Care Med. 2005 Apr;33(4):721-6. doi: 10.1097/01.ccm.0000159849.94750.51.
- Background: PubMed 15830325Goldman M, Webert KE, Arnold DM, Freedman J, Hannon J, Blajchman MA; TRALI Consensus Panel. Proceedings of a consensus conference: towards an understanding of TRALI. Transfus Med Rev. 2005 Jan;19(1):2-31. doi: 10.1016/j.tmrv.2004.10.001.
- Background: PubMed 13496693BRITTINGHAM TE. Immunologic studies on leukocytes. Vox Sang. 1957 Sep;2(4):242-8. doi: 10.1111/j.1423-0410.1957.tb03699.x. No abstract available.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
David F Stroncek, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Transfusion Reactions, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT00460122, which also lists 3 linked publications.
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 Dec 2019.