Troponin T and Emergency High-risk Abdominal Surgery
Association of Cardiac and Inflammatory Bio Markers and Morbidity in Emergency High-risk Abdominal Surgery
1 other identifier
observational
300
1 country
1
Brief Summary
To assess whether perioperatively elevated TnT levels, using high sensitivity troponin T (hsTnT) measurements, are associated with an increased risk of postoperative mortality as well as severe postoperative complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
1 active site
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
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedMay 11, 2021
May 1, 2021
1.1 years
May 4, 2021
May 7, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Death
30 days
Severe complication (Clavien Dindo ≥ 3)
30 days
Secondary Outcomes (3)
Death
90 days
Length of hospital stay
30 days
Length of ICU stay
30 days
Study Arms (1)
Emergency high-risk abdominal surgery
Patients undergoing emergency high-risk abdominal surgery, defined as immediate emergency laparoscopy or laparotomy, including intestinal obstruction, perforated viscus, intestinal ischemia and intraabdominal bleeding. Includes both primary surgery and re-operation after elective surgery.
Eligibility Criteria
All patients undergoing emergency high-risk abdominal surgery at Hvidovre Hospital, Denmark, that meet the criteria for inclusion. Hvidovre hospital serves as the primary emergency hospital for more than 500 000 inhabitants.
You may qualify if:
- Adults (18 years or over) undergoing emergency laparotomy or laparoscopy for following abdominal pathology:
- Intestinal obstruction
- Perforated viscus
- Intestinal ischemia
- Intraabdominal bleeding
- The above conditions include both primary surgery and re-operation after elective surgery.
You may not qualify if:
- Patients undergoing
- Appendicectomies
- Negative laparoscopies/laparotomies
- Cholecystectomies
- Simple herniotomies following incarceration without bowel resection
- Reoperation due to fascial separation with no other abdominal pathology identified
- Internal hernia after Roux-en-Y gastric bypass surgery
- Subacute surgery (surgery planned within 48 h) for inflammatory bowel diseases
- Subacute colorectal cancer surgery
- Patients with missing hsTnT values on both postoperative day 1 and 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark
Biospecimen
Blood samples
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 90 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 7, 2021
Study Start
March 1, 2021
Primary Completion
March 31, 2022
Study Completion
July 31, 2022
Last Updated
May 11, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share