Kidney DiseasesNC-CoactNCT04063423
Non- Clinical Coagulation Activation During Hemodialysis
An observational study of Kidney Diseases and End Stage Renal Disease, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Every patient included in the study will undergo 1 conventional hemodialysis treatment, ie 1 study visit. During the conventional hemodialysis treatment lasting 4 hours, 2 blood samples will be taken at different time points (5 minutes after dialysis start and 240 minutes after dialysis = at the end of the dialysis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, End Stage Renal Disease, Hemodialysis Complication
- What is being tested?
- blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Oct 2018to 1 May 2019
- 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
Study population: patients with end stage renal disease treated with hemodialysis
Who may be able to join
- ≥ 18 years of age.
- Patients able and agree to provide signed informed consent.
Who cannot join
- Known allergy for polysulphone dialysis membrane.
- Use of vitamin K antagonists or novel oral anticoagulant therapy.
- Use of chronic heparin treatment, UFH or LMWH.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non- Clinical Coagulation Activation During Hemodialysis: a Cross-sectional Study Evaluating Agreement and Correlation Between Hemodialysis Session Parameters, Biological Markers and Objective Measurements of Hemodialyzers: "NC-coact"
Every patient included in the study will undergo 1 conventional hemodialysis treatment, ie 1 study visit. During the conventional hemodialysis treatment lasting 4 hours, 2 blood samples will be taken at different time points (5 minutes after dialysis start and 240 minutes after dialysis = at the end of the dialysis session) to evaluate coagulation activation (TAT, PF1+2). Hemodialysis session parameters (arterial and venous pressure, TMP, OCM, BVM and prefilter pressure) will be noted at different time points (T5, T30, T60, T120, T180, T240). After discontinuation of the dialysis session, total cell volume will be measured using the Renatron II system® and the number of open fibers will be determined using micro-CT scanning.
- Being tested
- blood sample
- Keywords
- clotting, coagulation
- Medical subject headings
- Kidney Diseases, Kidney Failure, Chronic, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
Blood sample at start and at the end of the dialysis session; membrane scoring after dialysis; total cell volume measurement of dialyzer after dialysis; micro-CT of dialyzer after dialysis.
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis study session | * 4h hemodialysis session using standard polysulphone dialyzer and Nikkiso dialysis monitors
* Minimal dose of unfractionated heparin (UFH) with loading dose 500IE and maintenance 500IE/h, stopped 60 minutes before session end in case of AVF use.
* Standard bicarbonate-based ultrapure dialysate. Na, K, Ca, bicarbonate concentrations according to the patient's routine dialysis prescription.
* The blood flow rate maximized as per routine nursing care.
* Dialysate flow rate fixed at 500 ml/min.
* Dialysate temperature between 35.5°C and 36.5°C.
* Ultrafiltration according to patient's dry weight and supported ultrafiltration rate.
* At the end of the dialysis session the blood will be returned (100ml/min) to the patient. Receives: Procedure: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAT
thrombin antithrombin complex levels (mcg/L). Samples for TAT measurement were taken during the single hemodialysis study treatment. All patients underwent their study treatments between October - December 2018. All analyses were performed in batch in January 2019.
Measured: From first hemodialysis study session until interpretation of biological results, up to 6 months
open fibers
number of open fibers of dialyzer counted after microCT scanning of dialyzer membrane. Dialyzers were collected after the hemodialysis study treatment. All patients underwent their study treatments between October - December 2018. All micro CT scans were performed using the same scanner in Fabruary and March 2019.
Measured: From first hemodialysis study session until interpretation of scan results, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start25 Oct 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063423
- Sponsor's protocol ID
- UZB-NEF-2018-NC-COACT
- Acronym
- NC-Coact
- Status last verified
- Aug 2019
- First submitted
- 22 Jan 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non- Clinical Coagulation Activation During Hemodialysis: a Cross-sectional Study Evaluating Agreement and Correlation Between Hemodialysis Session Parameters, Biological Markers and Objective Measurements of Hemodialyzers: "NC-coact"
- ClinicalTrials.gov ID
- NCT04063423
- Acronym / sponsor ID
- NC-Coact / UZB-NEF-2018-NC-COACT
- Keywords
- clotting, coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 21 Aug 2019 (actual)
- 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.
Every patient included in the study will undergo 1 conventional hemodialysis treatment, ie 1 study visit. During the conventional hemodialysis treatment lasting 4 hours, 2 blood samples will be taken at different time points (5 minutes after dialysis start and 240 minutes after dialysis = at the end of the dialysis session) to evaluate coagulation activation (TAT, PF1+2). Hemodialysis session parameters (arterial and venous pressure, TMP, OCM, BVM and prefilter pressure) will be noted at different time points (T5, T30, T60, T120, T180, T240). After discontinuation of the dialysis session, total cell volume will be measured using the Renatron II system® and the number of open fibers will be determined using micro-CT scanning.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hemodialysis study session | – | Procedure: blood sample* 4h hemodialysis session using standard polysulphone dialyzer and Nikkiso dialysis monitors * Minimal dose of unfractionated heparin (UFH) with loading dose 500IE and maintenance 500IE/h, stopped 60 minutes before session end in case of AVF use. * Standard bicarbonate-based ultrapure dialysate. Na, K, Ca, bicarbonate concentrations according to the patient's routine dialysis prescription. * The blood flow rate maximized as per routine nursing care. * Dialysate flow rate fixed at 500 ml/min. * Dialysate temperature between 35.5°C and 36.5°C. * Ultrafiltration according to patient's dry weight and supported ultrafiltration rate. * At the end of the dialysis session the blood will be returned (100ml/min) to the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with end stage renal disease treated with hemodialysis
Key inclusion criteria (2 listed)
- ≥ 18 years of age.
- Patients able and agree to provide signed informed consent.
Key exclusion criteria (3 listed)
- Known allergy for polysulphone dialysis membrane.
- Use of vitamin K antagonists or novel oral anticoagulant therapy.
- Use of chronic heparin treatment, UFH or LMWH.
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 sampleBlood sample at start and at the end of the dialysis session; membrane scoring after dialysis; total cell volume measurement of dialyzer after dialysis; micro-CT of dialyzer after dialysis. | Procedure or surgery | hemodialysis study session |
Primary outcome
TAT
Time frame: From first hemodialysis study session until interpretation of biological results, up to 6 months
thrombin antithrombin complex levels (mcg/L). Samples for TAT measurement were taken during the single hemodialysis study treatment. All patients underwent their study treatments between October - December 2018. All analyses were performed in batch in January 2019.
open fibers
Time frame: From first hemodialysis study session until interpretation of scan results, up to 6 months
number of open fibers of dialyzer counted after microCT scanning of dialyzer membrane. Dialyzers were collected after the hemodialysis study treatment. All patients underwent their study treatments between October - December 2018. All micro CT scans were performed using the same scanner in Fabruary and March 2019.
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 21 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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 Kidney Diseases and End Stage Renal Disease, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 2 inclusion and 3 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 21 Aug 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 Belgium. 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?
TAT (time frame: From first hemodialysis study session until interpretation of biological results, up to 6 months). The study lists 2 primary outcomes in all. 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 21 Aug 2019.