Study Results
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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RECRUITING
5000 participants
OBSERVATIONAL
2021-10-12
2026-12-01
Brief Summary
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Objective: To describe the perioperative biomarker response in surgical patients with and without a postoperative complication and construct a preoperative and postoperative prediction model for postoperative complications. To systematically collect perioperative blood samples and clinical data in high-risk surgical patients for the development en analysis of biomarkers.
Study design: Multicenter, prospective, observational study. Study population: 4819 patients undergoing elective cardiac, colorectal, vascular and lung surgery.
Intervention (if applicable): Not applicable. Main study parameters/endpoints: Main study parameters are levels of PCT, CRPhs, IL-6, GDF-15, sFLT, NT-proBNP, cTNThs, CysC and NGAL. Main study endpoint is the occurrence of a major postoperative complication which is defined as a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death within 30 days of surgery.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In each patient five blood samples will be drawn for analysis. Most of the blood samples are drawn simultaneously with routine perioperative laboratory testing, which is common in this study population. In case a patient is admitted to the Intensive Care Unit blood samples will be collected using an arterial line. There are no direct risks or benefits for patients included in the study.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Biomarker
Perioperative biomarker analyses
Eligibility Criteria
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Inclusion Criteria
* Gastrointestinal surgery (colorectal, pancreatic, gastric surgery).
* Vascular surgery (open and endovascular aortic surgery, peripheral vascular surgery)
* Lung surgery (pneumonectomy,(bi)(sleeve)lobectomy or segmentectomy)
Exclusion Criteria
* Pregnancy
* Emergent surgery
* No informed consent
18 Years
ALL
No
Sponsors
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Roche Diagnostics GmbH
INDUSTRY
St. Antonius Hospital
OTHER
Responsible Party
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dr. P. Noordzij
Principal Investigator
Locations
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Amphia Hospital
Breda, North Brabant, Netherlands
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Peter Noordzij
Role: primary
References
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Noordzij PG, Ruven HJ, Reniers T, Idema RN, Thio MS, Cremer OL, Hollema N, Smit KN, Vernooij LM, Dijkstra IM, Rettig TC. Cohort profile of BIGPROMISE: a perioperative biobank of a high-risk surgical population. BMJ Open. 2024 Jun 11;14(6):e078307. doi: 10.1136/bmjopen-2023-078307.
Related Links
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Related Info
Other Identifiers
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NL7407610020
Identifier Type: -
Identifier Source: org_study_id