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The Role of Endogenous Heparinization As an Intraoperative Predictive Marker for Postoperative ICU Admission

NCT06799949 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-02-07

No results posted yet for this study

Summary

This prospective observational study investigates the role of endogenous heparinization as a predictive indicator for postoperative ICU admission. The phenomenon of endogenous heparinization is well documented with growing literature, investigating its clinical significance. The mechanisms leading to the pathogenesis of endogenous heparinization are the following: 1) Liver insufficiency in clearing circulating glycosaminoglycans (GAGs) due to acute liver failure, 2) Neutrophil-induced damage to hepatocytes, which results in releasing sulfated heparan, 3) Direct release of GAGs due to degradation of the endothelial glycocalyx. Furthermore, the endothelial glycocalyx shedding in response to pathological insults such as sepsis, ischemia-reperfusion injury, hyperglycemia, or trauma leads to increased vascular permeability, impaired microcirculation and systemic inflammation. This degradation is associated with several critical conditions, including acute kidney injury, cardiovascular diseases, and multi-organ failure, making glycocalyx shedding a crucial biomarker and therapeutic target. The aim of the study is to evaluate the correlation between intraoperative heparinization through the INTEM/HEPTEM ratio, as an indirect marker of endothelial glycocalyx integrity, and consequently, a biomarker of the patients' physiological status.

Conditions

  • Heparinization

Interventions

DIAGNOSTIC_TEST

ROTEM (TEM Innovations GmbH, Munich, Germany) assay

For each patient, two samples will be collected for ROTEM analysis: one at the beginning of the surgery, during the placement of the arterial line (Start ratio), and another one, at the end, during the completion of the surgical wound closure (Final ratio). The arterial line system will be filled with normal saline (0.9% sodium chloride) without the addition of unfractionated heparin. To avoid sample contamination before sampling, a volume of blood equivalent to 5.5-6 times the dead space (calculated from the catheter tip to the three-way stopcock device) will be aspirated. Blood samples for testing will be stored in specific empty coagulation test tubes (Jiangsu Rongye Technology Co., Ltd, Jiangsu, China) and gently mixed with 3.2%-0.109M sodium citrate, for a total volume of 1.8 ml.

Sponsors & Collaborators

  • Kotoulas Serafeim-Chrysovalantis

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-14
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06799949 on ClinicalTrials.gov