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Multicenter Study
. 2024 Jun 11;14(6):e078307.
doi: 10.1136/bmjopen-2023-078307.

Cohort profile of BIGPROMISE: a perioperative biobank of a high-risk surgical population

Peter G Noordzij  1   2 , Henk Jt Ruven  3 , Ted Reniers  4 , Rene N Idema  5 , Maaike Sy Thio  6 , Olaf L Cremer  7 , Nynke Hollema  4 , Kyra N Smit  3 , Lisette M Vernooij  4   2 , Ineke M Dijkstra  3 , Thijs Cd Rettig  6
Affiliations
Multicenter Study

Cohort profile of BIGPROMISE: a perioperative biobank of a high-risk surgical population

Peter G Noordzij et al. BMJ Open. .

Abstract

Purpose: Postoperative complications increase mortality, disability and costs. Advanced understanding of the risk factors for postoperative complications is needed to improve surgical outcomes. This paper discusses the rationale and profile of the BIGPROMISE (biomarkers to guide perioperative management and improve outcome in high-risk surgery) cohort, that aims to investigate risk factors, pathophysiology and outcomes related to postoperative complications.

Participants: Adult patients undergoing major surgery in two tertiary teaching hospitals. Clinical data and blood samples are collected before surgery, at the end of surgery and on the first, second and third postoperative day. At each time point a panel of cardiovascular, inflammatory, renal, haematological and metabolic biomarkers is assessed. Aliquots of plasma, serum and whole blood of each time point are frozen and stored. Data on severe complications are prospectively collected during 30 days after surgery. Functional status is assessed before surgery and after 120 days using the WHO Disability Assessment Schedule (WHODAS) 2.0. Mortality is followed up until 2 years after surgery.

Findings to date: The first patient was enrolled on 8 October 2021. Currently (1 January 2024) 3086 patients were screened for eligibility, of whom 1750 (57%) provided informed consent for study participation. Median age was 66 years (60; 73), 28% were female, and 68% of all patients were American Society of Anaesthesiologists (ASA) physical status class 3. Most common types of major surgery were cardiac (49%) and gastro-intestinal procedures (26%). The overall incidence of 30-day severe postoperative complications was 16%.

Future plans: By the end of the recruitment phase, expected in 2026, approximately 3000 patients with major surgery will have been enrolled. This cohort allows us to investigate the role of pathophysiological perioperative processes in the cause of postoperative complications, and to discover and develop new biomarkers to improve risk stratification for adverse postoperative outcomes.

Trial registration number: NCT05199025.

Keywords: adult surgery; cardiothoracic surgery; colorectal surgery; pancreatic surgery; risk factors; vascular surgery.

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Conflict of interest statement

Competing interests: PGN has participated in advisory boards for perioperative use of biomarkers, for which he has received a honorarium by Roche Diagnostics (Rotkreuz, Switzerland). PGN and TCDR have held lectures on perioperative biomarkers for which they have received a honorarium by Roche Diagnostics. OC has received research grants from ImmuneXpress Inc. (Seattle, WA) and Abionic SA (Epalinges, Switzerland) for related work.

Figures

Figure 1
Figure 1
Potential perioperative pathways in the pathogenesis of postoperative complications.
Figure 2
Figure 2
Perioperative collection, analysis and storage of blood samples.
See this image and copyright information in PMC

References

    1. Weiser TG, Haynes AB, Molina G, et al. . Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. The Lancet 2015;385:S11. 10.1016/S0140-6736(15)60806-6 - DOI - PubMed
    1. Crawford TC, Magruder JT, Grimm JC, et al. . Complications after cardiac operations: all are not created equal. Ann Thorac Surg 2017;103:32–40. - PubMed
    1. Paun BC, Cassie S, MacLean AR, et al. . Postoperative complications following surgery for rectal cancer. Ann Surg 2010;251:807–18. 10.1097/SLA.0b013e3181dae4ed - DOI - PubMed
    1. Paul S, Sedrakyan A, Chiu YL, et al. . Outcomes after lobectomy using thoracoscopy vs thoracotomy: a comparative effectiveness analysis utilizing the nationwide inpatient sample database. Eur J Cardiothorac Surg 2013;43:813–7. 10.1093/ejcts/ezs428 - DOI - PubMed
    1. International Surgical Outcomes Study Group . Global patient outcomes after elective surgery: prospective cohort study in 27 Low-, middle- and high-income countries. Br J Anaesth 2016;117:601–9. 10.1093/bja/aew316 - DOI - PMC - PubMed

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