Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512623
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
Cytokine Adsorption During Complex Cardiac Surgery a Controlled Randomized Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cytokine Adsorption During Complex Cardiac Surgery the JACCS Controlled Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JACCS
Brief Summary:
This prospective single-centre randomized controlled trial aims at evaluating the safety and efficacy of hemoadsorption with HA-380 during cardio-pulmonary bypass in 40 patients undergoing complex cardiac surgery
Detailed Description:
Cardiopulmonary bypass CPB is an extracorporeal circuit used to divert blood from the heart and lungs and take over their functions during cardiac surgery Cardiac surgery with CPB can induce a major inflammatory response largely mediated by cytokines In the most severe cases this inflammation can lead to vasoplegia hypotension and potentially end-organ damage
The investigators hypothesised that the removal of inflammatory mediators eg cytokines from the blood during CPB could reduce the development of postoperative complications in patients with significant inflammation during cardiac surgery
Patients undergoing complex cardiac surgery will be enrolled preoperatively and randomised 11 to receive either the investigational hemoadsorption treatment plus standard care intervention group or standard care alone control group Patients allocated to the intervention group will have an HA-380 cartridge Jafron Biomedical Guangdong China inserted into the CPB during circuit set-up Hemoadsorption treatment will be performed throughout the duration of the CPB procedure
For each patient 4 blood samples will be taken for cytokine measurements at the start of CPB 2 hours later at ICU admission and 24 hours later Data on vital signs organs support demographics and medical history will be collected in the electronic medical record
The investigators hypothesised that the removal of inflammatory mediators eg cytokines from the blood during CPB could reduce the development of postoperative complications in patients with significant inflammation during cardiac surgery
Patients undergoing complex cardiac surgery will be enrolled preoperatively and randomised 11 to receive either the investigational hemoadsorption treatment plus standard care intervention group or standard care alone control group Patients allocated to the intervention group will have an HA-380 cartridge Jafron Biomedical Guangdong China inserted into the CPB during circuit set-up Hemoadsorption treatment will be performed throughout the duration of the CPB procedure
For each patient 4 blood samples will be taken for cytokine measurements at the start of CPB 2 hours later at ICU admission and 24 hours later Data on vital signs organs support demographics and medical history will be collected in the electronic medical record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None