Bleeding Management İn Open Heart Surgery

January 16, 2026 updated by: Serkan Uckun

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The decision regarding blood and blood product transfusions will be made based on clinical observation by an anesthesiologist, which is our current routine practice.
Active Comparator: Group T
Blood clotting tests are performed with the device.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Anesthesia continues during cardiopulmonary bypass exit (4 to 5 hours after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Serkan Uckun

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHTEG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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