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| Name | Class |
|---|---|
| Persimune | UNKNOWN |
| University of Copenhagen | OTHER |
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This study aims to investigate whether preoperative soluble urokinase plasminogen activating receptor (suPAR) and High-sensitivity C-Reactive Protein (hsCRP) are independent markers of death after cardiac surgery. Further, to assess whether suPAR and hsCRP provides increased predictive accuracy of the clinical risk model EuroSCORE II. The purpose of the study is to gain knowledge on whether these inflammatory biomarkers might be able to reveal a pro-inflammatory disease state that represents a significant risk in patients undergoing cardiovascular surgery. Hence, these biomarkers may assist clinicians in selecting compassionate treatment for high risk patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elective on-pump cardiac surgery patients | Adult patients (≥18 years) undergoing elective on-pump cardiac surgery (isolated coronary artery bypass graft (CABG), single and multiple valvular procedures, combined CABG and valvular surgery, and others). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | Analysis will be performed using commercially available analyses (suPARnostic® kit (validated to measure suPAR concentrations between 0.6 and 22 ng/mL) (ViroGates)). HsCRP will be measured by high sensitivity CRP assays (Tina-quant hs-CRP latex assay (validated to measure CRP concentrations between 0.3 - 20 mg/L) (Roche/Hitachi)). In patients with CRP>20 mg/L a regular CRP-measurement will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Association of preoperative suPAR values in relation to the censored time-to-event outcome "death from any cause" | from index surgery to censoring date 12.31.2018 |
| Measure | Description | Time Frame |
|---|---|---|
| Association of preoperative hsCRP values in relation to the censored time-to-event outcome "death from any cause" | from index surgery to censoring date 12.31.2018 | |
| Assess whether adding suPAR, hsCRP or combined suPAR+hsCRP measurements improves predictive accuracy of EuroSCORE II |
| Measure | Description | Time Frame |
|---|---|---|
| 30 days mortality measured by a yes/no question of "all-cause mortality" | from index surgery to 30 days | |
| 1-year mortality measured by a yes/no question of "all-cause mortality" | from index surgery to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients (≥18 years) undergoing cardiac surgery at department of Cardiothoracic Surgery at Rigshospitalet, Copenhagen University Hospital, Denmark
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian R Rasmussen, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiothoracic Anaesthesiology, Rigshospitalet | Copenhagen | 2100 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 6, 2020 | Feb 24, 2020 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2020 | Feb 24, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples:
The blood samples for the study were drawn preoperatively or within 24 hours of surgery and stored in the Persimune Biobank or two other biobanks at Dept. Cardiothoracic Anaesthesiology and Dept. Cardiothoracic Surgery, Rigshospitalet.
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| from index surgery to 30 days postoperative |
| Sensitivity of the models; EuroSCORE II, suPAR, hsCRP, suPAR+hsCRP, EuroSCOREII+suPAR, EuroSCOREII+hsCRP and EuroSCOREII+suPAR+hsCRP in relation to the time-to-event outcome "death from any cause" | from index surgery to 30 days postoperative |
| Specificity of the models; EuroSCORE II, suPAR, hsCRP, suPAR+hsCRP, EuroSCOREII+suPAR, EuroSCOREII+hsCRP and EuroSCOREII+suPAR+hsCRP in relation to the time-to-event outcome "death from any cause" | from index surgery to 30 days postoperative |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |