ThrombocytopeniaNCT01356576
Effect of Hemodialysis Membranes on Platelet Count
An observational study of Thrombocytopenia, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if there is a drop in platelet count after hemodialysis. Hemodialysis membranes are known to activate complement and cause a drop in platelets and sometimes in white blood cells. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thrombocytopenia
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2011
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were being selected from the community where undergoing dialysis.
Who may be able to join
- Patients on Hemodialysis for >=6 months
Who cannot join
- Hematological Cancers
- Myelodysplastic syndromes
- Baseline thrombocytopenia
- Acute infections (patients on antibiotics)
- Patients with Immune thrombocytopenic purpura (ITP)/Thrombotic thrombocytopenic purpura (TTP)
- HIV
- Liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Island Rehabilitative Service
Staten Island, New York, 10305
About this study
The purpose of this study is to determine if there is a drop in platelet count after hemodialysis. Hemodialysis membranes are known to activate complement and cause a drop in platelets and sometimes in white blood cells. The investigators are going to study one of the membranes which is the Fresenius Optiflux® to check if it causes a drop in platelets.
- Conditions
- Thrombocytopenia
- Medical subject headings
- Thrombocytopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop in platelet counts
Measured: 90 minutes through hemodialysis and immediately after finishing hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Staten Island University Hospital
- Responsible party
- Principal investigator, Edward Epstein, Northwell Health
- Investigators
- Edwerd Epstein, M.D., Principal investigator, Staten Island University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356576
- Sponsor's protocol ID
- 10-039
- Status last verified
- Feb 2014
- First submitted
- 13 May 2011
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hemodialysis Membranes on Platelet Count
- ClinicalTrials.gov ID
- NCT01356576
- Acronym / sponsor ID
- 10-039
- Conditions
- Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Staten Island University Hospital
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 May 2011 (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.
The purpose of this study is to determine if there is a drop in platelet count after hemodialysis. Hemodialysis membranes are known to activate complement and cause a drop in platelets and sometimes in white blood cells. The investigators are going to study one of the membranes which is the Fresenius Optiflux® to check if it causes a drop in platelets.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were being selected from the community where undergoing dialysis.
Key inclusion criteria (1 listed)
- Patients on Hemodialysis for >=6 months
Key exclusion criteria (7 listed)
- Hematological Cancers
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
Drop in platelet counts
Time frame: 90 minutes through hemodialysis and immediately after finishing hemodialysis
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 7 Feb 2014.
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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.
Edwerd Epstein, M.D. principal investigator
Staten Island University Hospital
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 Thrombocytopenia, run by Northwell Health 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 1 inclusion and 7 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 7 Feb 2014. 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.
What does the primary outcome measure?
Drop in platelet counts (time frame: 90 minutes through hemodialysis and immediately after finishing hemodialysis). 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 7 Feb 2014.