NCT05339139

SAfety of Regional Citrate Anticoagulation (SARCA Study)

An Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO System in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fresenius Medical Care North America · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study).

Detailed description

In short, AKI is a major complication in intensive care patients, often occurring in the context of multiple organ failure, and some of these patients may need CRRT. The major advantage of CRRT is improved hemodynamic stability compared to intermittent HD. Continuous anticoagulation during CRRT may be needed to prevent premature clotting of the circuit and deliver the prescribed dialysis dose. Unfractionated heparin is the most commonly used anticoagulation during CRRT mainly as a result of familiarity, low cost, and ease of administration. But the main drawback is the risk of bleeding. An alternative technique to avoid systemic anticoagulation is regional extracorporeal anticoagulation with citrate (RCA). The advantages of RCA are improved circuit patency and fewer bleeding complications. The use of RCA may also reduce the ICU staff workload. Studies have shown longer filter running times which reduced circuit change and set-up time. In addition, anticoagulation related bleeding, and CRRT-related blood transfusions were minimized. Therefore, CRRT with RCA might be more economical than conventional anticoagulation. The study is to explore the possibility of using the multiFiltrate PRO system with the Ci-Ca module, Cifoban® (Trisodium citrate 4%), Calrecia® (Calcium chloride dihydrate), Ci-Ca dialysate K2 and K4, AV1000 (disposable cassette), and multiBic solution in subjects who are critically ill and receiving CRRT in an acute setting.

Conditions

• Acute Kidney Injury
• ESRD

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Dialysis	In this study critically ill adult patients requiring Continuous Renal Replacement Therapy (CRRT) will receive Regional Citrate Anticoagulation (CRA) which will be delivered by multiFiltratePRO system.

Timeline

• Start date: 2023-10-17
• Primary completion: 2025-04-30
• Completion: 2025-07-31
• First posted: 2022-04-21
• Last updated: 2025-04-24

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study