Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT05349669
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2022-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Jafron Haemoadsorption During Cardiopulmonary Bypass
Sponsor:
Anthea Hospital Bari
Organization:
Study Overview
Official Title:
Cytokine With Jafron Haemoadsorption During Cardiopulmonary Bypass: Protocol for Randomized Controlled Report
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JAFRONCPB
Brief Summary:
Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory response mediated by various cytokines. This response can, in severe cases, lead to systemic hypotension and organ dysfunction. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. Jafron is a device designed to remove cytokine from the blood using haemoadsorption (HA). This preliminary report aims to evaluate the potential of Jafron to decrease peri-operative cytokine levels in cardiac surgery.
Detailed Description:
In this context the investigators introduce the study design for multi-centre pilot randomized report in 40 patients undergoing elective CPB procedures with an expected time \>120 minutes for each extracorporeal procedure. Patients will be randomly allocated to either standard of care (n = 20) or Jafron HA(n = 20) during cardiopulmonary bypass (CPB). The primary outcome will be the difference between the two groups in cytokines levels (IL-2, IL-6,TNF-α, IFN gamma) and secondary parameters (Fibrinogen, Albumin, Platelets, Hemoglobin, Hematocrit, White Blood Cells, Neutrophils,Lymphocytes, Monocytes, Eosinophils, Basophils) will measured at anaesthesia induction, at the endof CPB , Primary outcomes: hemodynamics with or without vasoconstrictors use, the mechanical ventilation (MV) (hours) time and length of stay in intensive care unit (ICU) (hours). This prospectivemulti-centre randomized controlled report will take place in two Centres: Anthea Hospital, GVMCare \& Research, Bari, Italy; Virgen de la Arrixaca University Hospital, Murcia, Spain; between May 2022 and September 2022. The target population per centre will include (n=20) patients; will beallocate for each center to either standard of care (n = 10) or Jafron HA (n = 10) planned for elective cardiac surgery with increased risk of cytokine release.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: