NCT05199025: BIGPROMISE

Biomarkers in Perioperative Management

Recruiting now Last updated 2 December 2024

What this trial tests

trial testing Biomarker in Postoperative Complications in 5,000 participants. Currently enrolling.

Timeline

12 October 2021

Primary endpoint
1 June 2026

1 December 2026

Quick facts

Lead sponsor	St. Antonius Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	12 October 2021
Primary completion	1 June 2026
Estimated completion	1 December 2026
Sites	2 locations across Netherlands

Drugs / interventions tested

• Biomarker — full drug profile →

Conditions studied

• Postoperative Complications — all drugs for Postoperative Complications →
• Quality of Life — all drugs for Quality of Life →
• Death — all drugs for Death →

Sponsor

St. Antonius Hospital

Who can join

18 and older, any sex, with Postoperative Complications or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cohort profile of BIGPROMISE: a perioperative biobank of a high-risk surgical population.
   Noordzij PG, Ruven HJ, Reniers T, Idema RN, et al · · 2024 · cited 5× · PMID 38862228 · DOI 10.1136/bmjopen-2023-078307
2. Improving Prediction of Postoperative Atrial Fibrillation After Cardiac Surgery Using Multiple Pathophysiological Biomarkers: A Prospective Double-Centre Study.
   Noordzij PG, Thio MSY, Reniers T, Dijkstra I, et al · · 2025 · cited 1× · PMID 40507499 · DOI 10.3390/jcm14113737
3. Cohort profile of PLUTO: a perioperative biobank focusing on prediction and early diagnosis of postoperative complications.
   de Mul N, Verlaan D, Ruurda JP, van Grevenstein WMU, et al · · 2023 · cited 1× · PMID 37076142 · DOI 10.1136/bmjopen-2022-068970
4. Procalcitonin and interleukin-6 to diagnose infection in cardiac surgery patients with hyperinflammation: a two-centre, prospective cross-sectional study.
   Reniers T, Noordzij P, Harding E, Ruven H, et al · · 2026 · PMID 41768076 · DOI 10.1016/j.bjao.2026.100538