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NCT07850492

High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS)

Sponsor: Bach Mai Hospital

View on ClinicalTrials.gov

Summary

Major abdominal surgery (MAS) carries a high risk of 30-day mortality (\>5%). Perioperative myocardial injury (PMI) and myocardial injury after noncardiac surgery (MINS) frequently develop asymptomatically due to surgical analgesia. The 2022 European Society of Cardiology (ESC) Guidelines recommend routine surveillance with high-sensitivity cardiac troponin (hs-cTn) before and after surgery in high-risk patients, defining PMI by an absolute increase in hs-cTnT \>= 14 ng/L or a peak \> 5x ULN (\> 70 ng/L). However, validation in Asian populations and major abdominal visceral resections is scarce. This prospective observational cohort study (TROP-MAS) recruits \>= 650 consecutive high-cardiovascular-risk patients undergoing major abdominal surgery at Bach Mai Hospital (Hanoi, Vietnam). The study systematically evaluates the incidence and prognostic significance of hs-cTnT kinetics (T0 baseline, T1 24h, T2 48h postoperative) regarding 30-day all-cause mortality, major adverse cardiovascular events (MACE), and severe noncardiac complications (acute kidney injury, sepsis, anastomotic leak, bowel ischemia). Furthermore, it derives and validates population-specific optimal prognostic cut-off values using ROC curve analysis and multivariable Cox modeling.

Official title: Association Between High-Sensitivity Cardiac Troponin T Kinetics, Postoperative Complications, and 30-Day Mortality in Patients With Cardiovascular Risk Undergoing Major Abdominal Surgery: A Prospective Cohort Study

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

OBSERVATIONAL

Enrollment

650

Start Date

2026-10-01

Completion Date

2027-06-30

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

High-sensitivity cardiac troponin T (hs-cTnT) surveillance

Serial blood sampling for high-sensitivity cardiac troponin T (hs-cTnT) measurement using the Roche Cobas Elecsys STAT assay: preoperatively within 24 hours before incision (T0), at 24 hours (± 6h) postoperatively (T1), and at 48 hours (± 6h) postoperatively (T2). Additional samples are obtained if ischemic symptoms or signs occur.

Locations (1)

Bach Mai Hospital

Hanoi, Dong Da, Vietnam