Platelet FunctionNCT01837758
Monitoring Platelet Function During Continuous Hemodialysis
An observational study of Platelet Function, run by Goethe University at 1 site in Germany.
Trial summary
Aim of the study is a description of changes in platelet function during continuous veno-venous hemodialysis or hemofiltration in patients on an intensive care unit using the Multiplate system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Function
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to Aug 2013
- 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 in an intensive care unit with the need for a renal replacement therapy-
Who may be able to join
- Need for a continuous renal replacement therapy
- Platelet Count >100.000/nl
Who cannot join
- Pregnancy
- Age <18 years
- Renal replacement therapy within the 7 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johann Wolfgang Goethe-University
Frankfurt am Main, Hesse, 60590
About this study
Official title: Changes in Platelet Function During Continuous Veno-venous Hemodialysis Using the Multiplate Device
Aim of the study is a description of changes in platelet function during continuous veno-venous hemodialysis or hemofiltration in patients on an intensive care unit using the Multiplate system.
- Conditions
- Platelet Function
- Keywords
- Platelet function, hemofiltration, Multiplate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dialysis | Platelet function will be documented during the first 48 hours of veno-venous hemofiltration using the Multiplate system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASPItest
Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid at baseline and 6, 12, 24 and 48 hours after the start of the continuous hemofiltration.
Measured: Baseline, 6, 12, 24 and 48 hours
Secondary outcomes (4)
ADPtest
Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate at baseline and 6, 12, 24 and 48 hours after the start of the continuous hemofiltration.
Measured: Baseline, 6, 12, 24 and 48 hours
TRAPtest
Area under the aggregation curve (AUC) after platelet stimulation with thrombin-receptor-activating peptide 6 (TRAP-6) at baseline and 6, 12, 24 and 48 hours after the start of the continuous hemofiltration.
Measured: Baseline, 6, 12, 24, 48 hours
CT-INTEM
Clotting time (CT) in the intrinsically activated rotational thrombelastometry (ROTEM) recorded in seconds at baseline and 6, 12, 24 and 48 hours after the start of continuous veno-venous hemofiltration.
Measured: Baseline, 6, 12, 24 and 48 hours
MCF-INTEM
Maximum clot firmness (MCF) in the intrinsically activated rotational thrombelastometry (ROTEM) recorded in millimeters at baseline and 6, 12, 24 and 48 hours after the start of continuous veno-venous hemofiltration.
Measured: Baseline, 6, 12, 24 and 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2013
- Study completionAug 2013
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 Platelet FunctionStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saskia Wand, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837758
- Sponsor's protocol ID
- CVVH-Multiplate
- Status last verified
- Mar 2017
- First submitted
- 16 Apr 2013
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Daugirdas JT, Bernardo AA. Hemodialysis effect on platelet count and function and hemodialysis-associated thrombocytopenia. Kidney Int. 2012 Jul;82(2):147-57. doi: 10.1038/ki.2012.130. Epub 2012 May 16.
PubMed 22592187
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Platelet Function During Continuous Veno-venous Hemodialysis Using the Multiplate Device
- ClinicalTrials.gov ID
- NCT01837758
- Acronym / sponsor ID
- CVVH-Multiplate
- Conditions
- Platelet Function
- Keywords
- Platelet function, hemofiltration, Multiplate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Apr 2013 (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.
Aim of the study is a description of changes in platelet function during continuous veno-venous hemodialysis or hemofiltration in patients on an intensive care unit using the Multiplate system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis | – | –Platelet function will be documented during the first 48 hours of veno-venous hemofiltration using the Multiplate system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in an intensive care unit with the need for a renal replacement therapy-
Key inclusion criteria (2 listed)
- Need for a continuous renal replacement therapy
- Platelet Count >100.000/nl
Key exclusion criteria (3 listed)
- Pregnancy
- Age <18 years
- Renal replacement therapy within the 7 days prior to enrollment
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
ASPItest
Time frame: Baseline, 6, 12, 24 and 48 hours
Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid at baseline and 6, 12, 24 and 48 hours after the start of the continuous hemofiltration.
4 secondary outcomes
ADPtest
Time frame: Baseline, 6, 12, 24 and 48 hours
TRAPtest
Time frame: Baseline, 6, 12, 24, 48 hours
CT-INTEM
Time frame: Baseline, 6, 12, 24 and 48 hours
MCF-INTEM
Time frame: Baseline, 6, 12, 24 and 48hours
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 3 Mar 2017.
- Background: PubMed 22592187Daugirdas JT, Bernardo AA. Hemodialysis effect on platelet count and function and hemodialysis-associated thrombocytopenia. Kidney Int. 2012 Jul;82(2):147-57. doi: 10.1038/ki.2012.130. Epub 2012 May 16.
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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 Platelet Function, run by Goethe University at 1 site in Germany.
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 3 Mar 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 Germany. 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?
ASPItest (time frame: Baseline, 6, 12, 24 and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837758, 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 3 Mar 2017.