Efficacy and Safety of Heparin-grafted Membrane for CRRT (CARROM)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by National University Hospital, Singapore
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01779635
First received: January 27, 2013
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

The investigators hypothesize that the use of heparin-grafted membrane versus conventional membrane in critically-ill patients with bleeding-risk undergoing continuous renal replacement therapy, will effectively prolong the circuit lifespan, without worsening of the systemic APTT or underlying bleeding risk.


Condition Intervention
Acute Kidney Injury
Hemorrhage
Coagulopathy
Device: oXiris as first filter
Device: M150 as first filter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Continuous Renal Replacement Therapy With Anticoagulation-free Regimen in Bleeding-risk Patients Using oXiris Membrane - CARROM Study

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Circuit lifespan during continuous renal replacement therapy (up till termination as defined above) with each dialyzer (oXiris or M150) [ Time Frame: usually 10 - 30 hours from commencement of circuit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pre-circuit INR/APTT, and post-circuit INR/APTT 2 hours after termination. (We will be using the 2 hour post-circuit APTT result of the preceding dialyzer, as the pre-circuit APTT for the subsequent dialyzer. [ Time Frame: Usually after 10-30 hours when dialyzer clots ] [ Designated as safety issue: Yes ]
  • Serum urea/creatinine, and effluent urea/creatinine (paired samples) at 4 hrs from each circuit commencement, to examine "protein layering" and solute clearance. [ Time Frame: Usually 4 hours into circuit commencement ] [ Designated as safety issue: No ]
  • Transmembrane pressure (TMP), pressure drop across hemodiafilter (PDF), pressure in (PI), will be recorded on hourly basis throughout treatment, as per usual nursing protocol. [ Time Frame: over 10-30 hours of circuit running ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Total inotropic score, which is defined as total quantities of Dopamine + Dobutamine + 100 (Noradrenaline) + 100 (Adrenaline) in mcg/kg/min; pre- and post- use of the circuit. [ Time Frame: usually after 10-30 hours of circuit lifespan ] [ Designated as safety issue: No ]
  • Urine output over the 6 hours preceding the commencement of first circuit, and 6 hours after termination of the first circuit. [ Time Frame: Usually after 10-30 hours of circuit lifespan ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oXiris as first filter
Start off the first CRRT circuit with oXiris, then cross-over to M150, then oXiris, then back to M150
Device: oXiris as first filter
2 arms - each start off CRRT with either oXiris or M150 as first hemofilter, and then do cross-over to either hemofilters in a sequential manner when the former clots
M150 as first filter
Patients in M150 arm will start off with M150 as first filter for CRRT, then cross-over to oXiris after the former clots, then back to M150, then to oXiris.
Device: M150 as first filter
start off with M150 as first hemofilter, then cross-over to oXiris when former clots, and then to M150, and then lastly to oXiris

Detailed Description:

Aims and objectives:

We aim to compare the performance and safety of heparin-grafted AN69 membrane (oXiris, Gambro) with the conventional AN69 membrane (M150, Gambro) without systemic anticoagulation during continuous renal replacement therapy (CRRT), in critically ill patients with acute kidney injury (AKI) admitted to the intensive care unit (ICU), who has moderate bleeding risk and in whom systemic anticoagulation is contraindicated.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult patients (age 21 and above) who are admitted to ICUs or CCU and requiring CRRT for acute kidney injury or ESRD Patients who has moderate bleeding risk (see below definitions) Patients with NO systemic or regional circuit anticoagulation Informed consent taken from the patient, or proxy if the former is unable to sign due to medical reasons Anticipated need for prolonged CRRT > 3 days

(Moderate bleeding risk criteria:)

Moderate bleeding risk is defined by any of the following:

  1. Platelet count < 100 x 109 mm3 (but > 50)
  2. INR > 1.5 (but < 2.5)
  3. APTT > 50 seconds (but < 75)
  4. Post-surgery for < 48 hours
  5. Post-invasive procedures (eg. Pericardiocentasis) < 24 hrs
  6. Post major artery puncture or catheter removal from major arteries (carotids, subclavian, or femoral) < 24 hours
  7. Recent internal or gastrointestinal bleeding within 48 hours (should be secured bleeding with no relapse noted)

Exclusion Criteria:

Patients with very high bleeding risk (for which they should also fall outside of the below inclusion criteria - see below) Patients who are known to have heparin-induced thrombocytopenia or allergic to heparin Patients with other medical conditions for which heparin is contraindicated. Patients who require systemic anticoagulation for medical indications (We will accept patients who are on prophylactic doses of anticoagulation for DVT prophylaxis) Patients who are pregnant Patients/legally accepted surrogate who decline to consent

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779635

Contacts
Contact: Horng-Ruey Chua, MBBS +6567726178 horng.ruey.chua@gmail.com
Contact: Titus Lau, MD +6567722544 Titus_Lau@nuhs.edu.sg

Locations
Singapore
National University Hospital Not yet recruiting
Singapore, Singapore, 119228
Contact: Horng-Ruey Chua, MBBS    +6567726178    horng.ruey.chua@gmail.com   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Horng-Ruey Chua, MBBS National University Health System
  More Information

Publications:
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01779635     History of Changes
Other Study ID Numbers: DSRB 2012/02222, NKFRC/2012/01/11
Study First Received: January 27, 2013
Last Updated: January 29, 2013
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Heparin-grafted membrane
Circuit lifespan
Continuous renal replacement therapy
Anticoagulation free
Bleeding risk
Acute kidney injury
Critical illness

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhage
Acute Kidney Injury
Wounds and Injuries
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 31, 2014