Actively Recruiting
Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions: Prospective Observational Study
Led by Medical University Innsbruck · Updated on 2024-11-26
400
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best way to monitor anticoagulation in patients receiving unfractionated heparin (UFH) after major heart and vascular surgeries. The study aims to compare different anticoagulation monitoring methods such as activated clotting time (ACT), activated partial thromboplastin time (aPTT), viscoelastic tests (ROTEM), and anti-factor Xa levels. It also explores the relationship between inflammation, anticoagulation levels, adverse events like bleeding or thrombosis, and the occurrence of delirium after these surgeries. Patients undergoing heart surgery require full heparinization before using the heart-lung machine, with monitoring done during and after surgery using ACT and other tests. Those undergoing vascular surgery receive UFH intraoperatively and sometimes continuous infusion postoperatively. The study evaluates various monitoring tools in real-time to assess anticoagulation levels, inflammation markers, and related complications. Some patients receiving extracorporeal membrane oxygenation (ECMO) support are also included, with close monitoring of their anticoagulation needs. Participants will be followed for up to 30 days after surgery to track adverse events such as bleeding, thrombosis, inflammation, delirium, and the need for additional treatments like protamine. The study collects data from blood tests, coagulation monitoring tools, and clinical assessments to understand the links between anticoagulation, inflammation, and patient outcomes. This observational study does not involve experimental treatments but gathers detailed information to improve monitoring approaches.
CONDITIONS
Brief Title
Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 17 years
- Provided informed written consent
- Scheduled for cardiac intervention where unfractionated heparin use is expected (elective surgery)
- Scheduled for vascular intervention with expected perioperative anticoagulation (elective surgery)
- Patients receiving ECMO support
You will not qualify if you...
- Known pregnancy
- Current participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery and immediate recovery period
Participants undergo heart or vascular surgery with intraoperative anticoagulation monitoring using activated clotting time (ACT) and other tests during surgery and immediately after.
Continuous monitoring during hospital stay
Duration - Up to 30 days after surgery
Participants are monitored for anticoagulation levels, inflammation, and potential complications including delirium for up to 30 days after surgery.
Multiple visits during the 30-day follow-up period
Trial Site Locations
Total: 1 location
1
Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
Research Team
S
Sasa Rajsic, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here