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

NCT06799949 | Active Not Recruiting

• 1 other identifier: Ε.Σ.: 842 / 14-01-2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endogenous Heparinization; Predictive Marker; Postoperative ICU Admission; Prospective Observational Study; Endothelial Glycocalyx; ROTEM; Major Surgery

Outcome Measures

Primary Outcomes (1)

• Need for Postoperative ICU Admission

  At the end of the surgery, the decision for the patient's postoperative ICU admission will be based on commonly used criteria in clinical practice and the Anesthesiology, who will decide that will be blinded to the research.

  24 hours

Study Arms (1)

Adult patients undergoing elective or urgent major abdominal surgeries

* Inclusion Criteria: 1. Adult patients (\>18 years old) undergoing elective or urgent major abdominal surgeries. 2. ASA ≥ II and/or Surgical Risk score ≥ III 3. The attending anesthetist's opinion * Exclusion Criteria: 1. Emergency surgeries where preoperative anticoagulant/antiplatelet discontinuation guidelines were not followed. 2. Patients with liver cirrhosis, trauma and sepsis. 3. Pregnant or women on reproductive age. 4. Children 5. Neurosurgical, cardiovascular and transplantation procedures 6. Patient's refusal to participate

Diagnostic Test: ROTEM (TEM Innovations GmbH, Munich, Germany) assay

Interventions

ROTEM (TEM Innovations GmbH, Munich, Germany) assay DIAGNOSTIC_TEST

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.

Adult patients undergoing elective or urgent major abdominal surgeries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50 patients who will fulfill all the above mentioned inclusion criteria and none of the above mentioned exclusion criteria, will be included in the study. Furthermore, when a patient will meet those criteria a random number generator which will produce only two results (0/1) will be used to decide whether a patient will be included in the study or not.

You may qualify if:

• Adult patients (\>18 years old) undergoing elective or urgent major abdominal surgery.
• ASA ≥ II and/or Surgical Risk score ≥ III
• The attending anesthetist's opinion

You may not qualify if:

• Emergency surgeries where preoperative anticoagulant/antiplatelet discontinuation guidelines were not followed.
• Patients with liver cirrhosis, trauma and sepsis.
• Pregnant or women on reproductive age.
• Children
• Neurosurgical, cardiovascular and transplantation procedures
• Patient's refusal to participate

Sponsors & Collaborators

• Kotoulas Serafeim-Chrysovalantis: lead

Study Sites (1)

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, Thessaloniki, 54642, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for ROTEM (TEM Innovations GmbH, Munich, Germany) assays

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 29, 2025
• Study Start: January 14, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD and supporting information will be available after the publication of the results of the study, which is expected to take place within 2025, with no expiration date.
• Access Criteria: The IPD and supporting information will be accessible to everyone, upon request to the leading author of the publication that will result from this study

Locations

GR (1)