National University Hospital
Singapore, 119228
NCT Number: NCT01779635
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.
Looking for future studies?
Notify Me21 year and older
All sexes
Interventional
Not applicable
Singapore, 119228
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
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
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
start off with M150 as first hemofilter, then cross-over to oXiris when former clots, and then to M150, and then lastly to oXiris
Time frame: usually 10 - 30 hours from commencement of circuit
Circuit lifespan
Time frame: Usually after 10-30 hours when dialyzer clots
effect on coagulation status
Time frame: Usually 4 hours into circuit commencement
effect on clearance
Time frame: over 10-30 hours of circuit running
effect on circuit pressures
Time frame: usually after 10-30 hours of circuit lifespan
effect on hemodynamics
Time frame: Usually after 10-30 hours of circuit lifespan
effect on oliguria
National University Hospital, Singapore
Other
Continuous Renal Replacement Therapy With Anticoagulation-free Regimen in Bleeding-risk Patients Using oXiris Membrane - CARROM Study
Acronym: CARROM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04615065
Acute Disease, Acute Kidney Injury
Groningen, Netherlands
View Trial DetailsNCT04962412
Acute Kidney Injury, Critical Illness
Shanghai, China
View Trial DetailsNCT02962102
Acute Kidney Injury, Critical Illness
Boston, Massachusetts, United States
View Trial DetailsNCT07195565
Acute Kidney Injury, Burns
Istanbul, Turkey (Türkiye)
View Trial Details