CPPF After General Cardiac Surgery

NCT05308589 | Terminated DMC

• 1 other identifier: NL74428
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Continuous Postoperative Pericardial Flush (CPPF); CABG; Retained Blood Syndrome; Chest tubes [Mesh]; Blood Transfusion [mesh]; Therapeutic irrigation [Mesh]

Outcome Measures

Primary Outcomes (1)

• Incidence of re-exploration

  The incidence of re-exploration for either cardiac tamponade and/or excessive bleeding due to non-surgical bleeding.

  7 days

Secondary Outcomes (6)

• To assess safety and feasibility of the Haermonics investigational device

  8 hours

• Hct-sensor validation

  8 hours

• Number of participants with new onset postoperative fibrillation requiring medical therapy or electrocardioversion (ECV)

  during hospital stay, average of 3-7 days

• To investigate the clinical effects of CPPF on the use of blood products and administration of coagulation factors

  during hospital stay, average of 3-7 days

• To investigate the clinical effects of CPPF on the use of blood products and administration of coagulation factors

  during hospital stay, average of 3-7 days

Other Outcomes (1)

• To assess cost-effectiveness

  3 months

Study Arms (2)

Continuous Postoperative Pericardial Flushing

EXPERIMENTAL

Continuous Postoperative Pericardial Flushing (inflow of 500 ml NaCl 0,9% flushing fluid into the pericardial cavity during the first 8 postoperative hours) executed with the Haermonics investigational device

Device: CPPF

Control

NO INTERVENTION

Standard care

Interventions

CPPF DEVICE

Continuous Postoperative Pericardial Flush

Continuous Postoperative Pericardial Flushing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject should be scheduled for a general cardiothoracic surgery procedure with the use of cardiopulmonary bypass, amongst others, the main categories are;
• Coronary artery bypass grafting (CABG),
• Valve surgery,
• CABG combined with valve surgery
• Elective patients scheduled for aortic surgery (including valve sparing root replacement (VSRR), Bentall procedures, ascending aorta- aortic arch replacement)
• Including the initial study population:
• Patients scheduled for CABG with continued DAPT
• Patients with aIE scheduled for valve replacement
• Patients scheduled for complex or multiple cardiac (redo) procedures with an (expected) CPB time \>300 minutes
• Patients undergoing aortic surgery with DHCA

You may not qualify if:

• Euroscore II \> 20%
• Intraoperatively diaphragm injury leading to an open connection between the thoracic and abdominal cavity
• Age \< 18
• Inability to understand study information
• Participation in any study involving an investigational drug or device
• Emergent procedures
• Procedures performed off pump, without the use of cardiopulmonary bypass.
• Minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Haermonics BV: collaborator
• European Regional Development Fund: collaborator

Study Sites (4)

Amsterdam UMC

Amsterdam, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

MeSH Terms

Conditions

Cardiac Tamponade; Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• R. Klautz, Prof

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 4, 2022
• Study Start: November 2, 2021
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

NL (4)