Predictive Value of suPAR and hsCRP on Postoperative Mortality in Cardiac Surgery

Predictive Value of suPAR and hsCRP on Postoperative Mortality in 951 Patients Undergoing Elective On-pump Cardiac Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04292249

Enrollment

951

Registered

2020-03-03

Start date

2012-08-06

Completion date

2019-12-16

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers, Cardiac Surgical Procedures, Thoracic Surgery

Brief summary

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.

Interventions

OTHERBlood 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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Planned elective on-pump cardiac surgery (isolated coronary artery bypass graft (CABG), single and multiple valvular procedures, combined CABG and valvular surgery, and others) * Given informed consent on delivering a blood sample for the biobank.

Exclusion criteria

* Peroperatively cancelling the surgery * Sudden change to off-pump coronary artery bypass (OPCAB) surgery * Death prior to surgery * Project blood samples not available.

Design outcomes

Primary

Measure	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

Secondary

Measure	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	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

Other

Measure	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026