Bleeding Management İn Open Heart Surgery

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Thromboelastography (TEG) Bleeding Hemorrhage Open Heart Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who will undergo open heart surgery
Patients who have given informed consent

Exclusion criteria

Patients undergoing emergency surgery
Patients with known congenital coagulation disorders
Patients with a known history of bleeding diathesis
Patients receiving uninterrupted anticoagulant therapy at an optimal time
Patients with renal failure under dialysis treatment
Patients with active malignancy
Patients who did not provide informed consent

Treatment and study plan

Blood Product

Diagnostic Test

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.

Primary outcomes

Targeted coagulation therapy

Time frame: A total of three measurements will be take After induction of anesthesia (Between 15 and 30 minutes of the operation) During cardiopulmonary bypass (2 hours after the start of surgery) Following cardiopulmonary bypass (4 hours after the start of surgery)

Measurement of R time using thromboelastography Measurement of K time using thromboelastography Measurement of maximum amplitude using thromboelastography

Secondary outcomes

Use of blood products

Time frame: Anesthesia continues during cardiopulmonary bypass exit (4 to 5 hours after surgery)

Optimizing the use of fibrinogen, platelets, and fresh frozen plasma by combining thromboelastography measurements with clinical interpretation

Sponsors and collaborators

Lead sponsor

Serkan Uckun

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jan 26, 2026
Registry last updated: Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting