Bleeding Management İn Open Heart Surgery

ConditionsThromboelastography (TEG)Open Heart Surgery Bleeding

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-84

SponsorSerkan Uckun

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who will undergo open heart surgery

Patients who have given informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

140 Participants

are divided into 2 treatment groups

Group A: ControlNo intervention 0 interventions

Group B: Group TActive comparator 1 intervention

Trial outcomes

Primary outcomes

Targeted coagulation therapy

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

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)

Secondary outcomes

Use of blood products

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

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Serkan Uckun

Lead sponsor

Balikesir University

Sponsor institution

Source ClinicalTrials.gov

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