HeparinizationNCT06799949
The Role of Endogenous Heparinization As an Intraoperative Predictive Marker for Postoperative ICU Admission
An observational study of Heparinization, run by Kotoulas Serafeim-Chrysovalantis at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparinization
- What is being tested?
- ROTEM (TEM Innovations GmbH, Munich, Germany) assay
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 14 Jan 2025to 30 Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, Thessaloniki, 54642
About this study
Official title: The Role of Endogenous Heparinization As an Intraoperative Predictive Marker for Postoperative ICU Admission: a Prospective Observational Study
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.
Read the detailed description
This prospective study will include all adult patients scheduled for an elective or urgent major abdominal surgery, who are going to be evaluated preoperatively in our center (Ippokrateio General Hospital of Thessaloniki) The study will be conducted in compliance with ethical standards (Declaration of Helsinki) and has already obtained the approval of the scientific council (Ethics Committee) of our hospital. For every patient informed consent will be obtained. The justification of the request for preoperative ICU bed reservation is going to be based on three criteria: patient's ASA classification, the Surgical Risk score and the attending anaesthetist's opinion and clinical judgment. Patients undergoing neurosurgical, cardiovascular and transplantation procedures will be excluded. All patients will follow the preoperative anticoagulation/antiplatelet discontinuation guidelines. Patients' demographic data, medical history and the necessary laboratory evaluation will be recorded. On the day of the operation the standard anesthetic protocol according to the type of the surgery will be followed and the ESAIC (European Society of Anaesthesia and Intesive Care) standard monitoring will be deployed. All patients are going to receive general anaesthesia. The use of locoregional anaesthesia (epidural, spinal, combined and nerve blocks) mechanical ventilation parameters, hemodynamic parameters, fluid management, ABG analysis results will be recorded in a thorough manner. After anaesthesia induction an arterial line will be placed for direct measurement of arterial pressure, blood gas monitoring of the patient, and simultaneous collection of samples for ROTEM (TEM Innovations GmbH, Munich, Germany) assays. 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 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 specialized evacuated 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. At the end of the surgery, the decision for the patient's postoperative ICU admission will be based on those criteria
- Mental status: Awake and cooperative.
- Oxygenation: PaO₂/FiO₂ ratio ≥ 150-200.
- Ventilation: PaCO₂ < 50 mmHg or baseline.
- RSBI<105.
- Respiratory effort: Spontaneous breathing, no excessive work of breathing.
- Cardiovascular:HR < 140/min; SBP 90-160 mmHg with minimal to no vasopressors.
- Neuromuscular function: TOF ratio ≥ 0.9.
- Attending anaesthetist's opinion and clinical judgement In case of the patients' successful extubation, the risk of re-intubation will be monitored for 24 hours.
- Conditions
- Heparinization
- Being tested
- ROTEM (TEM Innovations GmbH, Munich, Germany) assay
- Keywords
- Endogenous Heparinization, Predictive Marker, Postoperative ICU Admission, Prospective Observational Study, Endothelial Glycocalyx, ROTEM, Major Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEM (TEM Innovations GmbH, Munich, Germany) assayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: ROTEM (TEM Innovations GmbH, Munich, Germany) assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start14 Jan 2025
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeparinizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kotoulas Serafeim-Chrysovalantis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kotoulas Serafeim-Chrysovalantis, Ippokrateio General Hospital of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799949
- Sponsor's protocol ID
- Ε.Σ.: 842 / 14-01-2025
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data with no individual-identifying information
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Endogenous Heparinization As an Intraoperative Predictive Marker for Postoperative ICU Admission: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06799949
- Acronym / sponsor ID
- Ε.Σ.: 842 / 14-01-2025
- Conditions
- Heparinization
- Keywords
- Endogenous Heparinization, Predictive Marker, Postoperative ICU Admission, Prospective Observational Study, Endothelial Glycocalyx, ROTEM, Major Surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kotoulas Serafeim-ChrysovalantisUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective study will include all adult patients scheduled for an elective or urgent major abdominal surgery, who are going to be evaluated preoperatively in our center (Ippokrateio General Hospital of Thessaloniki) The study will be conducted in compliance with ethical standards (Declaration of Helsinki) and has already obtained the approval of the scientific council (Ethics Committee) of our hospital. For every patient informed consent will be obtained. The justification of the request for preoperative ICU bed reservation is going to be based on three criteria: patient's ASA classification, the Surgical Risk score and the attending anaesthetist's opinion and clinical judgment. Patients undergoing neurosurgical, cardiovascular and transplantation procedures will be excluded. All patients will follow the preoperative anticoagulation/antiplatelet discontinuation guidelines. Patients' demographic data, medical history and the necessary laboratory evaluation will be recorded. On the day of the operation the standard anesthetic protocol according to the type of the surgery will be followed and the ESAIC (European Society of Anaesthesia and Intesive Care) standard monitoring will be deployed. All patients are going to receive general anaesthesia. The use of locoregional anaesthesia (epidural, spinal, combined and nerve blocks) mechanical ventilation parameters, hemodynamic parameters, fluid management, ABG analysis results will be recorded in a thorough manner. After anaesthesia induction an arterial line will be placed for direct measurement of arterial pressure, blood gas monitoring of the patient, and simultaneous collection of samples for ROTEM (TEM Innovations GmbH, Munich, Germany) assays. 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 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 specialized evacuated 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. At the end of the surgery, the decision for the patient's postoperative ICU admission will be based on those criteria
- Mental status: Awake and cooperative.
- Oxygenation: PaO₂/FiO₂ ratio ≥ 150-200.
- Ventilation: PaCO₂ < 50 mmHg or baseline.
- RSBI<105.
- Respiratory effort: Spontaneous breathing, no excessive work of breathing.
- Cardiovascular:HR < 140/min; SBP 90-160 mmHg with minimal to no vasopressors.
- Neuromuscular function: TOF ratio ≥ 0.9.
- Attending anaesthetist's opinion and clinical judgement In case of the patients' successful extubation, the risk of re-intubation will be monitored for 24 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing elective or urgent major abdominal surgeries | – | Diagnostic Test: ROTEM (TEM Innovations GmbH, Munich, Germany) assay* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROTEM (TEM Innovations GmbH, Munich, Germany) assayFor 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. | Diagnostic test | Adult patients undergoing elective or urgent major abdominal surgeries |
Primary outcome
Need for Postoperative ICU Admission
Time frame: 24 hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Yes. Raw data with no individual-identifying information
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heparinization, run by Kotoulas Serafeim-Chrysovalantis at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for Postoperative ICU Admission (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.