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Citrate Anticoagulation During MARS Treatment

Primary Purpose

Liver Failure

Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
trisodiumcitrate
trisodiumcitrate
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Failure focused on measuring MARS treatment, Citrate anticoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled MARS treatment
  • Age over 18 years
  • Informed consent
  • Admitted to Intensive Care Unit

Exclusion Criteria:

  • Blood or plasma transfusion within 48 hours before study
  • Hypocalcemia (ionised Ca < 0.90 mmol/l)
  • Acidosis (pH < 7.25) due to any cause
  • Use of citrate containing medications

Sites / Locations

  • Universitaire Ziekenhuizen LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

citrate first

no anticoagulation first

Outcomes

Primary Outcome Measures

Extracorporeal circuit coagulation events

Secondary Outcome Measures

Citrate tolerability
Treatment efficacy

Full Information

First Posted
June 10, 2008
Last Updated
March 4, 2009
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT00695617
Brief Title
Citrate Anticoagulation During MARS Treatment
Official Title
Citrate Anticoagulation During MARS Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The optimal anticoagulation procedure during MARS treatment has not been defined. In various multi-centre trials, such as MARS-RELIEF, anticoagulation procedures are left to the discretion of the treating physician. On the one hand, given the increased risk of bleeding associated with liver failure, high dosage of anticoagulation therapy should be avoided. On the other hand, contact of blood or blood components with the extracorporeal circuit will likely result in coagulation activation or even loss of coagulation factors. Citrate anticoagulation has gained popularity, especially in hemodialysis patients. It results in a highly effective anticoagulation, exclusively confined to the extracorporeal circulation. Moreover, dependent on the type of dialyser membrane, citrate anticoagulation resulted in reduced activation of other cellular components. In contrast to hemodialysis patients, experience with citrate anticoagulation during treatment with artificial liver devices is limited. The liver contributes substantially to the metabolism of exogenous citrate. As a result, cirrhotic patients have decreased endogenous citrate clearances. Importantly, blood purification devices contribute substantially to overall citrate clearance, thereby preventing accumulation of citrate. Several centres, including our own, have gained experience with citrate anticoagulation during fractionated plasma separation and adsorption (FPSA), a related liver dialysis device, in the treatment of liver failure patients. Citrate anticoagulation during MARS treatment has not been studied so far.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure
Keywords
MARS treatment, Citrate anticoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
citrate first
Arm Title
B
Arm Type
Experimental
Arm Description
no anticoagulation first
Intervention Type
Drug
Intervention Name(s)
trisodiumcitrate
Intervention Description
trisodiumcitrate 1.035 M
Intervention Type
Drug
Intervention Name(s)
trisodiumcitrate
Intervention Description
trisodiumcitrate 1.035 M
Primary Outcome Measure Information:
Title
Extracorporeal circuit coagulation events
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Citrate tolerability
Time Frame
6 hours
Title
Treatment efficacy
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled MARS treatment Age over 18 years Informed consent Admitted to Intensive Care Unit Exclusion Criteria: Blood or plasma transfusion within 48 hours before study Hypocalcemia (ionised Ca < 0.90 mmol/l) Acidosis (pH < 7.25) due to any cause Use of citrate containing medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pieter Evenepoel, MD, PhD
Phone
+32 16 344580
Email
pieter.evenepoel@uz.kuleuven.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Bjorn Meijers, MD
Phone
+32 16 342352
Email
bjorn.meijers@uz.kuleuven.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter Evenepoel, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bjorn Meijers, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Wilmer, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederik Nevens, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Björn Meijers, MD
Phone
+32 16 342352
Email
bjorn.meijers@uz.kuleuven.ac.be
First Name & Middle Initial & Last Name & Degree
Bjorn Meijers, MD
First Name & Middle Initial & Last Name & Degree
Pieter Evenepoel, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17640311
Citation
Meijers BK, Verhamme P, Nevens F, Hoylaerts MF, Bammens B, Wilmer A, Arnout J, Vanrenterghem Y, Evenepoel P. Major coagulation disturbances during fractionated plasma separation and adsorption. Am J Transplant. 2007 Sep;7(9):2195-9. doi: 10.1111/j.1600-6143.2007.01909.x. Epub 2007 Jul 19.
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Citrate Anticoagulation During MARS Treatment

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