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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.
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 (e.g. 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 1:1 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, at the end of CPB, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care) | |
| Hemoadsorption | Experimental | Cardiopulmonary bypass (CPB) will be conducted as per institutional protocols and an HA-380® cartridge (Jafron Biomedical, Guangdong, China) will be inserted within the circuit for hemoadsorption. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoadsoprtion | Device | The hemoadsorption treatment will be performed during the entire duration of the CPB. Blood flow within the cartridge is standardized at 250 ml/min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SOFA score at 24 hours | Difference between groups in the SOFA score measured within 24 hours after ICU admission | Within 24 hours of ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| ICU and hospital length of stay | Lengths of stays, in days | At time of hospital discharge, an average 20 days after ICU admission |
| ICU, hospital, and 28 days (from ICU admission) mortality | All-cause mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related complications | Technical failure to perform the treatment (thrombosis of cartridge, circuit leak, inability to perform the treatment for all CPB duration) | During cardiopulmonary bypass |
| Treatment tolerance |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine Schneider | CHUV Centre Hospitalier Universitaire Vaudois (CHUV) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002318 | Cardiovascular Diseases |
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| At time of hospital discharge, an average 20 days after ICU admission and up to 28 days after ICU admission |
| Days alive without respiratory support | Number of days alive and without mechanical ventilation | At day 28 from ICU admission |
| Days alive without renal replacement therapy | Number of days alive and without renal replacement therapy | At day 28 from ICU admission |
| Days alive without vasopressors | Number of days alive and without vasopressors | At day 28 from ICU admission |
| SOFA score at 48 hours | Sequential Organ Failure Assessment (SOFA) difference between groups in the SOFA score measured between 24hours and 48 hours after ICU admission. The higher the SOFA the highest the probability of death | Measured between 24 hours and 48 hours after ICU admission |
| Post-operative complications | Post-operative Acute Kidney Injury, transfusion of red blood cells, sepsis, delirium, liver injury or need for coronary angiography | At time of ICU discharge, up to 7 days after ICU admission |
| Cytokines levels | Relative and absolute reduction in the plasma levels of cytokines at different timepoints, compared with their levels at baseline (immediately before CPB initiation). | at the end of CPB, at the admission in ICU and 24 hours after ICU admission |
New allergic or anaphylactoid reaction (stage ≥ 2 according to H. L. Mueller [39]) or new fever (> 38.5°C)
| During cardiopulmonary bypass |
| Safety of intervention | Bleeding and haematological complications Post-operative infections New acute organ rejection | From beginning of cardiopulmonary bypass to 7 days after ICU admission, |
| Feasibility of intervention | Screened to enrolled patients' ratio, success of intervention delivery in intervention group, duration of recruitment | During cardiopulmonary bypass |