Bleeding Management İn Open Heart Surgery

Serkan Uckun

Status: Begins enrollment in 1 month

Conditions: Open Heart Surgery; Thromboelastography (TEG); Bleeding

Treatments: Diagnostic Test: Blood Product

Study type: Interventional

Funder types: Other

Identifiers

NCT07366606

AHTEG

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Control

No Intervention group

Description:

The decision regarding blood and blood product transfusions will be made based on clinical observation by an anesthesiologist, which is our current routine practice.

Group T

Active Comparator group

Description:

Blood clotting tests are performed with the device.

Treatment:

Diagnostic Test: Blood Product