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

NCT ID: NCT04292249

Last Updated: 2020-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

951 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-06

Study Completion Date

2019-12-16

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracic Surgery Cardiac Surgical Procedures Biomarkers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

Blood sampling

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Persimune

UNKNOWN

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Roed Rasmussen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sebastian R Rasmussen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Department of Cardiothoracic Anaesthesiology, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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H-18002379

Identifier Type: -

Identifier Source: org_study_id

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