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NCT05308589: FLUID

CPPF After General Cardiac Surgery

Terminated NA Last updated 14 May 2024
What this trial tests

NA trial testing CPPF in Cardiac Surgical Procedures in 164 participants. Terminated before completion.

Timeline
2 November 2021
Primary endpoint
18 April 2023
18 April 2023

Quick facts

Lead sponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment164
Start date2 November 2021
Primary completion18 April 2023
Estimated completion18 April 2023
Sites4 locations across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

18 and older, any sex, with Cardiac Surgical Procedures or Retained Blood Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In two randomized clinical trials the investigators have demonstrated that continuous postoperative pericardial flushing (CPPF) therapy can reduce postoperative blood loss and bleeding-related complications after cardiac surgery and that CPPF therapy is safe and feasible in an experimental setting. The Haermonics investigational device is a novel medical device that enables CPPF therapy to be used in daily clinical setting. The aim of this study is three-fold. First, to evaluate the safety and functionality of the Haermonics investigational device. Secondly, to investigate the effect of CPPF therapy on bleeding related complications in the adulty cardiac surgery population. Thirdly, to explore the effect of CPPF therapy on intraluminal chest tube clogging.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effects of Continuous Postoperative Pericardial FLUshing with Investigational Device on Postoperative Re-Explorations for Bleeding (FLUID)-Randomized Clinical Trial.
    Molenaar MA, Koolbergen DR, Vegter M, Lam K, et al · · 2026 · PMID 41899076 · DOI 10.3390/jcm15062151

Verify or expand the search:

Other recruiting trials for Cardiac Surgical Procedures

Currently open trials in the same condition.

Other Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05308589.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing