NCT05642273: CLEAN ECMO

The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO

Completed NA Last updated 29 March 2024

What this trial tests

NA trial testing oXiris membrane in Cardiogenic Shock in 40 participants. Completed in 8 January 2024.

Timeline

25 November 2022

Primary endpoint
8 January 2024

8 January 2024

Quick facts

Lead sponsor	Samsung Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	25 November 2022
Primary completion	8 January 2024
Estimated completion	8 January 2024
Sites	1 location across South Korea

Drugs / interventions tested

• oXiris membrane
• Blood tests — full drug profile →

Conditions studied

• Cardiogenic Shock — all drugs for Cardiogenic Shock →

Sponsor

Samsung Medical Center

Who can join

18 and older, any sex, with Cardiogenic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cardiogenic shock (CS) defines a state of systemic hypo-perfusion leading to end-organ dysfunction related to cardiac pump failure and with mortality rates in the range of 27-50% according to recent reviews. Patients with CS often received mechanical circulatory support, and venoarterial extracorporeal membrane oxygenator (V-A ECMO) is an effective tool to support refractory CS while ensuring continuous organ perfusion. Patients with CS present clinical signs of systemic inflammation and elevated plasma levels of prototypical inflammatory and vasoactive mediators, including C-reactive protein (CRP), Interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα). As data is scarce in this field, we decided to perform a prospective randomized controlled pilot study to investigate the efficacy of extracorporeal cytokine and lipopolysaccharide adsorption using Oxiris on humoral inflammation parameters, hemodynamics, and clinical outcomes in patients with CS requiring VA ECMO.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extending the 'host response' paradigm from sepsis to cardiogenic shock: evidence, limitations and opportunities.
   Buckel M, Maclean P, Knight JC, Lawler PR, et al · · 2023 · cited 19× · PMID 38012789 · DOI 10.1186/s13054-023-04752-8
2. The admission level of CRP during cardiogenic shock is a strong independent risk marker of mortality.
   Roubille F, Cherbi M, Kalmanovich E, Delbaere Q, et al · · 2024 · cited 5× · PMID 39014136 · DOI 10.1038/s41598-024-67556-y
3. The effects of extracorporeal blood purification (oXiris®) in patients with cardiogenic shock who require VA-ECMO (CLEAN ECMO): a prospective, open-label, randomized controlled pilot study.
   Ko RE, Choi KH, Lee K, Jeon J, et al · · 2025 · cited 3× · PMID 40542431 · DOI 10.1186/s13054-025-05495-4
4. Glimpse into the future.
   Moller JE, Mangner N, Pappalardo F, Thiele H. · · 2023 · cited 1× · PMID 38093769 · DOI 10.1093/eurheartjsupp/suad133
5. Interleukin-6 in Cardiogenic Shock.
   Fazzini L, Golino M, Moroni F, Castrichini M, et al · · 2025 · PMID 40884675 · DOI 10.1007/s11886-025-02273-0