An observational study in Thoracic Surgery, Cardiac Surgical Procedures and Biomarkers, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by Copenhagen University Hospital, Rigshospitalet · Observational
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.
Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 39 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥18 years) undergoing cardiac surgery at department of Cardiothoracic Surgery at Rigshospitalet, Copenhagen University Hospital, Denmark
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Exclusion Criteria:
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).
Other: Blood sampling
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.
Association of preoperative suPAR values in relation to the censored time-to-event outcome "death from any cause"
Time frame: from index surgery to censoring date 12.31.2018
Association of preoperative hsCRP values in relation to the censored time-to-event outcome "death from any cause"
Time frame: 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
Time frame: 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"
Time frame: 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"
Time frame: from index surgery to 30 days postoperative
30 days mortality measured by a yes/no question of "all-cause mortality"
Time frame: from index surgery to 30 days
1-year mortality measured by a yes/no question of "all-cause mortality"
Time frame: from index surgery to 1 year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Aug 2012 to primary completion in Jun 2019, 82 months.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital, Rigshospitalet