Biomarkers in Perioperative Management
BIGPROMISE
Biomarkers to Guide Perioperative Management and Improve Outcome in High-risk Surgery
1 other identifier
observational
5,000
1 country
2
Brief Summary
Rationale: The rate of postoperative complications after high-risk surgery remains high despite recent advances in perioperative management. There is a lack of objective and reliable information that can be used for risk stratification and to guide treatment decisions. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2021
CompletedFirst Submitted
Initial submission to the registry
January 6, 2022
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 27, 2026
April 1, 2026
4.6 years
January 6, 2022
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative complication
a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death
30 days
Secondary Outcomes (4)
Failure to rescue
30 days
Mortality
120 days
DAH120
120 days
Disability
120 days
Interventions
Perioperative biomarker analyses
Eligibility Criteria
The study population consists of patients undergoing surgery in the St. Antonius Hospital and the Amphia hospital.
You may qualify if:
- Cardiac surgery (isolated coronary artery bypass grafting or combined with single valve surgery, isolated single valve surgery)
- Gastrointestinal surgery (colorectal, pancreatic, gastric surgery).
- Vascular surgery (open and endovascular aortic surgery, peripheral vascular surgery)
- Lung surgery (pneumonectomy,(bi)(sleeve)lobectomy or segmentectomy)
You may not qualify if:
- Age \< 18 years
- Pregnancy
- Emergent surgery
- No informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Antonius Hospitallead
- Roche Diagnostics GmbHcollaborator
Study Sites (2)
Amphia Hospital
Breda, North Brabant, 4818CK, Netherlands
St Antonius Hospital
Nieuwegein, Utrecht, 3430 EM, Netherlands
Related Publications (2)
Reniers T, Noordzij P, Harding E, Ruven H, Thio M, Langelaan M, Dijkstra I, Vernooij L, Cremer O, Rettig TCD. Procalcitonin and interleukin-6 to diagnose infection in cardiac surgery patients with hyperinflammation: a two-centre, prospective cross-sectional study. BJA Open. 2026 Feb 19;17:100538. doi: 10.1016/j.bjao.2026.100538. eCollection 2026 Mar.
PMID: 41768076DERIVEDNoordzij 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.
PMID: 38862228DERIVED
Related Links
Biospecimen
Human blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 6, 2022
First Posted
January 20, 2022
Study Start
October 12, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 27, 2026
Record last verified: 2026-04