HepZero:Heparin Free Dialysis With Evodial
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01318486 |
Recruitment Status :
Completed
First Posted : March 18, 2011
Last Update Posted : April 5, 2017
|
Sponsor:
Baxter Healthcare Corporation
Collaborators:
Statistical Analysis : CIC CHU Brabois Nancy
Gambro Lundia AB
Information provided by (Responsible Party):
Baxter Healthcare Corporation
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | March 11, 2011 | |||
First Posted Date ICMJE | March 18, 2011 | |||
Last Update Posted Date | April 5, 2017 | |||
Study Start Date ICMJE | March 2011 | |||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Clotting of the dialysis session [ Time Frame: During first dialysis session_Dialysis duration: 4 hours ] To evaluate the rate of successful treatments, clotting in the air traps will be evaluated using a scale grading from 1 to 4 and previously described in the literature.
The first heparin free dialysis treatment will be considered successful when there is:
|
|||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | HepZero:Heparin Free Dialysis With Evodial | |||
Official Title ICMJE | HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups | |||
Brief Summary | The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
266 | |||
Original Estimated Enrollment ICMJE |
252 | |||
Actual Study Completion Date ICMJE | February 2013 | |||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, France, Netherlands, Poland, Spain, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01318486 | |||
Other Study ID Numbers ICMJE | 1483 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Baxter Healthcare Corporation | |||
Study Sponsor ICMJE | Baxter Healthcare Corporation | |||
Collaborators ICMJE |
|
|||
Investigators ICMJE |
|
|||
PRS Account | Baxter Healthcare Corporation | |||
Verification Date | April 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |