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CPPF After General Cardiac Surgery

NCT05308589 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2024-05-14

No results posted yet for this study

Summary

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.

Conditions

  • Cardiac Surgical Procedures
  • Retained Blood Syndrome
  • Cardiac Tamponade
  • Postoperative Hemorrhage

Interventions

DEVICE

CPPF

Continuous Postoperative Pericardial Flush

Sponsors & Collaborators

  • Haermonics BV

    collaborator INDUSTRY

  • European Regional Development Fund

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • R. Klautz, Prof · Amsterdam UMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2023-04-18
Completion
2023-04-18

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05308589 on ClinicalTrials.gov