Bleeding Management İn Open Heart Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Product.
- Who it may be relevant to
- Registry conditions: Thromboelastography (TEG), Open Heart Surgery, Bleeding. Basic parameters: 18 years — 84 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of a Thromboelastography-Based Algorithm for Targeted Bleeding Management in Open Heart Surgery: An In Vitro Clinical Study
Overview
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.
Interventions
- 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, in
Primary outcome measures
- 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)]
Secondary outcome measures (1)
- Use of blood products [Time frame: Anesthesia continues during cardiopulmonary bypass exit (4 to 5 hours after surgery)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07366606 · AHTEG