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

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. Identifier: NCT01779635
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Kidney Injury Hemorrhage Coagulopathy Device: oXiris as first filter Device: M150 as first filter Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized initiation with oXiris versus M150 (conventional filter), with cross-over for subsequent circuits.
Masking: None (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
Actual Study Start Date : August 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    Circuit lifespan

Secondary Outcome Measures :
  1. 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 ]
    effect on coagulation status

  2. 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 ]
    effect on clearance

  3. 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 ]
    effect on circuit pressures

Other Outcome Measures:
  1. 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 ]
    effect on hemodynamics

  2. 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 ]
    effect on oliguria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01779635

National University Hospital
Singapore, Singapore, 119228
Sponsors and Collaborators
National University Hospital, Singapore
Principal Investigator: Horng-Ruey Chua, MBBS National University Health System

Responsible Party: National University Hospital, Singapore Identifier: NCT01779635     History of Changes
Other Study ID Numbers: DSRB 2012/02222
NKFRC/2012/01/11 ( Other Grant/Funding Number: National Kidney Foundation Singapore )
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Acute Kidney Injury
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action