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

National University Health System (NUHS)

Status: Completed

Conditions: Coagulopathy; Hemorrhage; Acute Kidney Injury

Treatments: Device: M150 as first filter; Device: oXiris as first filter

Study type: Interventional

Funder types: Other

Identifiers

NCT01779635

DSRB 2012/02222

NKFRC/2012/01/11 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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:

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

oXiris as first filter

Active Comparator group

Description:

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

Treatment:

Device: oXiris as first filter

M150 as first filter

Other group

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.

Treatment:

Device: M150 as first filter