Back to results

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

Primary Purpose

Acute Kidney Injury, Hemorrhage, Coagulopathy

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

oXiris as first filter

M150 as first filter

About this trial

This is an interventional supportive care trial for Acute Kidney Injury focused on measuring Heparin-grafted membrane, Circuit lifespan, Continuous renal replacement therapy, Anticoagulation free, Bleeding risk, Acute kidney injury, Critical illness

Eligibility Criteria

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

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:

Platelet count < 100 x 109 mm3 (but > 50)
INR > 1.5 (but < 2.5)
APTT > 50 seconds (but < 75)
Post-surgery for < 48 hours
Post-invasive procedures (eg. Pericardiocentasis) < 24 hrs
Post major artery puncture or catheter removal from major arteries (carotids, subclavian, or femoral) < 24 hours
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

Sites / Locations

National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

oXiris as first filter

M150 as first filter

Arm Description

Start off the first CRRT circuit with oXiris, then cross-over to M150, then oXiris, then back to M150

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.

Outcomes

Primary Outcome Measures

Circuit lifespan during continuous renal replacement therapy (up till termination as defined above) with each dialyzer (oXiris or M150)

Circuit lifespan

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.

effect on coagulation status

Serum urea/creatinine, and effluent urea/creatinine (paired samples) at 4 hrs from each circuit commencement, to examine "protein layering" and solute clearance.

effect on clearance

Transmembrane pressure (TMP), pressure drop across hemodiafilter (PDF), pressure in (PI), will be recorded on hourly basis throughout treatment, as per usual nursing protocol.

effect on circuit pressures

Full Information

NCT ID

NCT01779635

First Posted

January 27, 2013

Last Updated

May 25, 2017

Sponsor

National University Hospital, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT01779635

Brief Title

Efficacy and Safety of Heparin-grafted Membrane for CRRT

Acronym

CARROM

Official Title

Continuous Renal Replacement Therapy With Anticoagulation-free Regimen in Bleeding-risk Patients Using oXiris Membrane - CARROM Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

August 2013 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National University Hospital, Singapore

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury, Hemorrhage, Coagulopathy

Keywords

Heparin-grafted membrane, Circuit lifespan, Continuous renal replacement therapy, Anticoagulation free, Bleeding risk, Acute kidney injury, Critical illness

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomized initiation with oXiris versus M150 (conventional filter), with cross-over for subsequent circuits.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oXiris as first filter

Arm Type

Active Comparator

Arm Description

Start off the first CRRT circuit with oXiris, then cross-over to M150, then oXiris, then back to M150

Arm Title

M150 as first filter

Arm Type

Other

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

oXiris as first filter

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

M150 as first filter

Intervention Description

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 Measure Information:

Title

Circuit lifespan during continuous renal replacement therapy (up till termination as defined above) with each dialyzer (oXiris or M150)

Description

Circuit lifespan

Time Frame

usually 10 - 30 hours from commencement of circuit

Secondary Outcome Measure Information:

Title

Description

effect on coagulation status

Time Frame

Usually after 10-30 hours when dialyzer clots

Title

Serum urea/creatinine, and effluent urea/creatinine (paired samples) at 4 hrs from each circuit commencement, to examine "protein layering" and solute clearance.

Description

effect on clearance

Time Frame

Usually 4 hours into circuit commencement

Title

Transmembrane pressure (TMP), pressure drop across hemodiafilter (PDF), pressure in (PI), will be recorded on hourly basis throughout treatment, as per usual nursing protocol.

Description

effect on circuit pressures

Time Frame

over 10-30 hours of circuit running

Other Pre-specified Outcome Measures:

Title

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.

Description

effect on hemodynamics

Time Frame

usually after 10-30 hours of circuit lifespan

Title

Urine output over the 6 hours preceding the commencement of first circuit, and 6 hours after termination of the first circuit.

Description

effect on oliguria

Time Frame

Usually after 10-30 hours of circuit lifespan

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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: Platelet count < 100 x 109 mm3 (but > 50) INR > 1.5 (but < 2.5) APTT > 50 seconds (but < 75) Post-surgery for < 48 hours Post-invasive procedures (eg. Pericardiocentasis) < 24 hrs Post major artery puncture or catheter removal from major arteries (carotids, subclavian, or femoral) < 24 hours 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Horng-Ruey Chua, MBBS

Organizational Affiliation

National University Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University Hospital

City

Singapore

ZIP/Postal Code

119228

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22773036

Citation

Schetz M, Van Cromphaut S, Dubois J, Van den Berghe G. Does the surface-treated AN69 membrane prolong filter survival in CRRT without anticoagulation? Intensive Care Med. 2012 Nov;38(11):1818-25. doi: 10.1007/s00134-012-2633-x. Epub 2012 Jul 7.

Results Reference

background

PubMed Identifier

12577144

Citation

Uchino S, Fealy N, Baldwin I, Morimatsu H, Bellomo R. Continuous is not continuous: the incidence and impact of circuit "down-time" on uraemic control during continuous veno-venous haemofiltration. Intensive Care Med. 2003 Apr;29(4):575-8. doi: 10.1007/s00134-003-1672-8. Epub 2003 Feb 8.

Results Reference

background

PubMed Identifier

17472846

Citation

Evenepoel P, Dejagere T, Verhamme P, Claes K, Kuypers D, Bammens B, Vanrenterghem Y. Heparin-coated polyacrylonitrile membrane versus regional citrate anticoagulation: a prospective randomized study of 2 anticoagulation strategies in patients at risk of bleeding. Am J Kidney Dis. 2007 May;49(5):642-9. doi: 10.1053/j.ajkd.2007.02.001.

Results Reference

background

PubMed Identifier

11193272

Citation

Tan HK, Baldwin I, Bellomo R. Continuous veno-venous hemofiltration without anticoagulation in high-risk patients. Intensive Care Med. 2000 Nov;26(11):1652-7. doi: 10.1007/s001340000691.

Results Reference

background

PubMed Identifier

23102533

Citation

Chua HR, Baldwin I, Bailey M, Subramaniam A, Bellomo R. Circuit lifespan during continuous renal replacement therapy for combined liver and kidney failure. J Crit Care. 2012 Dec;27(6):744.e7-15. doi: 10.1016/j.jcrc.2012.08.016. Epub 2012 Oct 24.

Results Reference

background

PubMed Identifier

34519356

Citation

Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of Heparin-grafted Membrane for CRRT

We'll reach out to this number within 24 hrs