Efficacy and Safety of Heparin-grafted Membrane for CRRT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Kidney Injury Hemorrhage Coagulopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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oXiris as first filter

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

Group Type ACTIVE_COMPARATOR

oXiris as first filter

Intervention Type DEVICE

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.

Group Type OTHER

M150 as first filter

Intervention Type DEVICE

start off with M150 as first hemofilter, then cross-over to oXiris when former clots, and then to M150, and then lastly to oXiris

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No