NCT07366606

Bleeding Management İn Open Heart Surgery

Development of a Thromboelastography-Based Algorithm for Targeted Bleeding Management in Open Heart Surgery: An In Vitro Clinical Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Serkan Uckun · Academic / Other
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

This study aims to develop an algorithm that can guide targeted bleeding management through thromboelastography (TEG) viscoelastic testing performed on blood samples from patients undergoing open heart surgery. The goal is to develop an algorithm that supports targeted bleeding management based on TEG parameters. The study is prospective, in vitro, and non-invasive. The material will consist of residual blood samples from open heart surgery patients. Analyses will be performed using TEG parameters (R time, K time, MA, LY30). Patients will be randomized using a closed-envelope method and divided into two groups: anesthesiologist standard clinical observation-control (Group K) and anesthesiologist standard clinical observation and TEG analysis (Group T). The sample size is 70 patients per group. From an ethical standpoint, this study uses anonymous data without additional blood collection and ensures patient safety.

Conditions

• Thromboelastography (TEG)
• Open Heart Surgery
• Bleeding

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood Product	R time, the time from the start of the test until the graph width reaches 2 mm (5-10 minutes), reflects the activity of clotting factors. K time, the time from the end of R until the width reaches 20 mm (1-3 minutes), represents the clot formation time and rate. alpha angle (53-72 degrees) represents fibrinogen function, maximum amplitude is related to platelet function (50-70 mm), represents maximum clot strength. lysis rate -30 (0% -8%) represents the clot lysis rate 30 minutes after MA, indicating whether hyperfibrinolysis is present.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2026-01-26
• Last updated: 2026-01-26