Efficacy and Safety of Heparin-grafted Membrane for CRRT

Not Applicable

Completed

• Conditions: Coagulopathy; Acute Kidney Injury; Hemorrhage
• Interventions: Device: M150 as first filter; Device: oXiris as first filter

• Registration Number: NCT01779635
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-01-27
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-30
• Study Start: 2013-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
M150 as first filter	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.
oXiris as first filter	oXiris as first filter	Start off the first CRRT circuit with oXiris, then cross-over to M150, then oXiris, then back to M150

Primary Outcome Measures

Name	Time	Method
Circuit lifespan during continuous renal replacement therapy (up till termination as defined above) with each dialyzer (oXiris or M150)	usually 10 - 30 hours from commencement of circuit	Circuit lifespan

Secondary Outcome Measures

Name	Time	Method
Serum urea/creatinine, and effluent urea/creatinine (paired samples) at 4 hrs from each circuit commencement, to examine "protein layering" and solute clearance.	Usually 4 hours into circuit commencement	effect on clearance
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.	Usually after 10-30 hours when dialyzer clots	effect on coagulation status
Transmembrane pressure (TMP), pressure drop across hemodiafilter (PDF), pressure in (PI), will be recorded on hourly basis throughout treatment, as per usual nursing protocol.	over 10-30 hours of circuit running	effect on circuit pressures

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore