ApheresisNCT00042627
Prevalence and Risk of Cataracts in Granulocyte Donors
An observational study of Apheresis, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will investigate whether people who donate granulocytes (a type of white blood cell) by leukapheresis are at increased risk of developing cataracts (changes in the lens of the eye that can impair vision). Apheresis is a method of collecting large numbers of white blood cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apheresis
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2002to 25 Jun 2007
- 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
- Signed and understood informed consent.
- Study subjects must be NIH DTM volunteer apheresis donors who have donated granulocytes on 4 or more occasions since 1984.
- Control subjects must be NIH DTM volunteer apheresis donors who have donated platelets on 4 or more occasions since 1984.
Who cannot join
- Persons less than 18 years old.
- Persons who have donated granulocytes outside DTM on more than four occasions.
- Persons who have donated platelets outside DTM on more than four occasions.
- Donors with a known history of cataracts will NOT be excluded.
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: Prevalence and Risks for Posterior Subcapsular Cataracts in Volunteer Granulocytapheresis Donors
This study will investigate whether people who donate granulocytes (a type of white blood cell) by leukapheresis are at increased risk of developing cataracts (changes in the lens of the eye that can impair vision). Apheresis is a method of collecting large numbers of white blood cells. The procedure is similar to donating whole blood, but the collected blood is circulated through a cell separator machine, the white cells are extracted, and the rest of the blood is returned to the donor. Before the procedure, donors are given a steroid called dexamethasone. This drug temporarily increases the number of granulocytes circulating in the blood, thus allowing twice as many of these cells to be collected.
Recently, one blood collection center reported greater numbers of cataracts in a small number of granulocyte donors who had received repeated doses of steroids for granulocyte mobilization. The donors were unaware that they had the cataracts, which were small and did not affect their vision. Although people who take high doses of steroids over a long period time are known to have an increased risk of cataracts, steroids given infrequently (and in the doses used for granulocyte donation) have not been associated with cataracts. This study will examine the eyes of granulocyte donors and of platelet donors. Platelets-blood components necessary for clotting-are also collected by pheresis, but donors are not given steroids before the procedure. The examination findings will be compared to see if there is a difference in the risk of cataract formation in the two groups.
Read more
People 18 years of age and older who have donated granulocytes or platelets at the NIH Department of Transfusion Medicine four times or more since 1984 may be eligible for this study. Participants will undergo the following procedures:
- Detailed medical history, including allergies, corticosteroid use, diabetes mellitus, and asthma
- Detailed eye history, including cataracts, glaucoma, other eye diseases and infections, eye trauma, and corrective lenses
- Detailed history of sun exposure
- Eye examination, including measurement of visual acuity (eye chart test) and eye pressure, examination of the lens and retina.
- Photographs of the eye using a special camera
Read the detailed description
An increased prevalence of cataracts was recently described in a small number of granulocyte donors who had received repeated doses of adrenal corticosteroids as part of their mobilization regimen for granulocyte donation. Mild posterior subcapsular cataracts (PSCs) were found in 4 of 11 (36%) of granulocyte donors versus 0 of 9 platelet donors. Though the relationship or corticosteroid administration to the development of PSCs is well established, not all steroid recipients develop such lesions. Observational studies suggest that the development of PSCs is an associated risk if steroids are given for a prolonged period of time (greater than 10 mg/day for 1-2 years). To maximize the cellular yield of granulocytapheresis procedures, granulocyte donors are given a single dose of an adrenal steroid the day prior to donation. Since 1984, it has been standard practice in the NIH Department of Transfusion Medicine (DTM) to administer dexamethasone 8 mg orally 12 hours prior to donation. Since 1996 both dexamethasone 8 mg orally as well as granulocyte colony-stimulating-factor (G-CSF) 5 microg/kg subcutaneously are administered on the day prior to donation to maximize cell yields during apheresis. It is also standard procedure in DTM to restrict granulocyte donation to once per month (12 times/year), with few medical exceptions. To determine the prevalence of ophthalmologic abnormalities, particularly PSCs, in DTM granulocyte donors, we propose to perform a medical history and comprehensive blinded ophthalmologic examination on all consenting granulocyte donors. Age and gender-matched volunteer plateletpheresis donors will be invited as controls. If an increase in the incidence of PSCs or other lens or eye abnormalities is found in the granulocyte donors compared with the plateletpheresis donors, we will attempt to correlate the factors operating during granulocyte donation that are related to this increased risk.
- Conditions
- Apheresis
- Keywords
- Cataracts, Granulocytapheresis, Granulocyte Donors
- Medical subject headings
- Cataract
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2002 (estimated)
- Study start30 Jul 2002
- Study completion25 Jun 2007
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 ApheresisStudies 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
- Enrolment
- 252 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042627
- Sponsor's protocol ID
- 020255
- Other IDs
- 02-EI-0255
- Status last verified
- 25 Jun 2007
- First submitted
- 1 Aug 2002
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Strauss RG. Therapeutic granulocyte transfusions in 1993. Blood. 1993 Apr 1;81(7):1675-8. No abstract available.
PubMed 8117344
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risks for Posterior Subcapsular Cataracts in Volunteer Granulocytapheresis Donors
- ClinicalTrials.gov ID
- NCT00042627
- Acronym / sponsor ID
- 020255
- Conditions
- Apheresis
- Keywords
- Cataracts, Granulocytapheresis, Granulocyte Donors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 30 Jul 2002
- Study completion
- 25 Jun 2007
- First posted
- 2 Aug 2002 (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 investigate whether people who donate granulocytes (a type of white blood cell) by leukapheresis are at increased risk of developing cataracts (changes in the lens of the eye that can impair vision). Apheresis is a method of collecting large numbers of white blood cells. The procedure is similar to donating whole blood, but the collected blood is circulated through a cell separator machine, the white cells are extracted, and the rest of the blood is returned to the donor. Before the procedure, donors are given a steroid called dexamethasone. This drug temporarily increases the number of granulocytes circulating in the blood, thus allowing twice as many of these cells to be collected.
Recently, one blood collection center reported greater numbers of cataracts in a small number of granulocyte donors who had received repeated doses of steroids for granulocyte mobilization. The donors were unaware that they had the cataracts, which were small and did not affect their vision. Although people who take high doses of steroids over a long period time are known to have an increased risk of cataracts, steroids given infrequently (and in the doses used for granulocyte donation) have not been associated with cataracts. This study will examine the eyes of granulocyte donors and of platelet donors. Platelets-blood components necessary for clotting-are also collected by pheresis, but donors are not given steroids before the procedure. The examination findings will be compared to see if there is a difference in the risk of cataract formation in the two groups.
People 18 years of age and older who have donated granulocytes or platelets at the NIH Department of Transfusion Medicine four times or more since 1984 may be eligible for this study. Participants will undergo the following procedures:
- Detailed medical history, including allergies, corticosteroid use, diabetes mellitus, and asthma
- Detailed eye history, including cataracts, glaucoma, other eye diseases and infections, eye trauma, and corrective lenses
- Detailed history of sun exposure
- Eye examination, including measurement of visual acuity (eye chart test) and eye pressure, examination of the lens and retina.
- Photographs of the eye using a special camera
Detailed description
An increased prevalence of cataracts was recently described in a small number of granulocyte donors who had received repeated doses of adrenal corticosteroids as part of their mobilization regimen for granulocyte donation. Mild posterior subcapsular cataracts (PSCs) were found in 4 of 11 (36%) of granulocyte donors versus 0 of 9 platelet donors. Though the relationship or corticosteroid administration to the development of PSCs is well established, not all steroid recipients develop such lesions. Observational studies suggest that the development of PSCs is an associated risk if steroids are given for a prolonged period of time (greater than 10 mg/day for 1-2 years). To maximize the cellular yield of granulocytapheresis procedures, granulocyte donors are given a single dose of an adrenal steroid the day prior to donation. Since 1984, it has been standard practice in the NIH Department of Transfusion Medicine (DTM) to administer dexamethasone 8 mg orally 12 hours prior to donation. Since 1996 both dexamethasone 8 mg orally as well as granulocyte colony-stimulating-factor (G-CSF) 5 microg/kg subcutaneously are administered on the day prior to donation to maximize cell yields during apheresis. It is also standard procedure in DTM to restrict granulocyte donation to once per month (12 times/year), with few medical exceptions. To determine the prevalence of ophthalmologic abnormalities, particularly PSCs, in DTM granulocyte donors, we propose to perform a medical history and comprehensive blinded ophthalmologic examination on all consenting granulocyte donors. Age and gender-matched volunteer plateletpheresis donors will be invited as controls. If an increase in the incidence of PSCs or other lens or eye abnormalities is found in the granulocyte donors compared with the plateletpheresis donors, we will attempt to correlate the factors operating during granulocyte donation that are related to this increased risk.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and understood informed consent.
- Study subjects must be NIH DTM volunteer apheresis donors who have donated granulocytes on 4 or more occasions since 1984.
- Control subjects must be NIH DTM volunteer apheresis donors who have donated platelets on 4 or more occasions since 1984.
Key exclusion criteria (4 listed)
- Persons less than 18 years old.
- Persons who have donated granulocytes outside DTM on more than four occasions.
- Persons who have donated platelets outside DTM on more than four occasions.
- Donors with a known history of cataracts will NOT be excluded.
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 2 Jul 2017.
- Background: PubMed 8117344Strauss RG. Therapeutic granulocyte transfusions in 1993. Blood. 1993 Apr 1;81(7):1675-8. No abstract available.
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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.
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 Apheresis, run by National Eye Institute (NEI) 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 3 inclusion and 4 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 2 Jul 2017. 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 NCT00042627, 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 2 Jul 2017.