NCT07366606

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

January 9, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 9, 2026

Last Update Submit

January 16, 2026

Conditions

Open Heart SurgeryThromboelastography (TEG)Bleeding

Outcome Measures

Primary Outcomes (1)

  • Targeted coagulation therapy

    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 Outcomes (1)

  • Use of blood products

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

Study Arms (2)

Control

NO INTERVENTION

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

Blood clotting tests are performed with the device.

Diagnostic Test: Blood Product

Interventions

Blood ProductDIAGNOSTIC_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.

Group T

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 26, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01