Heart SurgeryPAC-AIMNCT06222866
Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions
An observational study of Heart Surgery and Vascular Surgery, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The goal of this prospective observational study is to evaluate the most appropriate anticoagulation monitoring tool for unfractionated heparin (UFH), by comparison of different monitoring modalities in relation to adverse events occurrence (thrombosis/bleeding). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Surgery, Vascular Surgery, Delirium
- What is being tested?
- Anticoagulation monitoring
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- 25 Jun 2024to 1 Dec 2026
- 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: All patients needing cardiac or vascular surgery who receive anticoagulation
Who may be able to join
- Age: > 17 years
- Informed written consent
- Scheduled for cardiac intervention where the use of UFH is expected (elective surgery)
- Scheduled for vascular intervention when the need for perioperative anticoagulation is expected (elective surgery)
- Patients receiving ECMO support
Who cannot join
- Patients that are known to be pregnant
- Known participation in other interventional clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Sasa Rajsic, MD, PhD, 004367763004447, sasa.rajsic@tirol-kliniken.at
Sasa Rajsic, MD, PhD
About this study
Official title: Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions: Prospective Observational Study
The goal of this prospective observational study is to evaluate the most appropriate anticoagulation monitoring tool for unfractionated heparin (UFH), by comparison of different monitoring modalities in relation to adverse events occurrence (thrombosis/bleeding).
The main study questions are:
Read more
- What is the most appropriate anticoagulation monitoring tool (ACT, aPTT, viscoelastic tests (ROTEM), and anti-Xa) for UFH
- What is the incidence of adverse events associated with anticoagulation and inflammation after heart and vascular interventions
- Is there an association of available anticoagulation thresholds and monitoring tests with bleeding and/or thrombosis occurrence
- Is there an association of inflammation with delirium
Secondary study objectives include:
- Association of anticoagulation levels as measured by ACT, aPTT, viscoelastic tests (ROTEM), and anti-factor-Xa with adverse events
- Correlation of each anticoagulation monitoring test with the UFH anti-Xa measurement
- Correlation of each anticoagulation monitoring test with another (ACT, aPTT, ROTEM, anti-F-Xa) and the amount of blood loss post surgery
- The incidence of UFH-rebound effect and the need for protamine application
- Association of inflammation and increased / reduced need for anticoagulation titration
- Correlation of anticoagulation dosing with anticoagulation monitoring tests and adverse events
- The association of inflammation with adverse events
- The association and impact of inflammation on measured levels of anticoagulation with available tests
- Influence of anticoagulation on mortality
- Incidence of ECMO support
- Incidence of delirium (hypoactive and hyperactive) and correlation with vital (newly onset postoperative atrial fibrillation amongst others) and laboratory parameters, including, and pre-existing neurological disorders
Read the detailed description
Patients undergoing major heart and vascular surgery are often in need of intraoperative and/or postoperative anticoagulation. To ensure the appropriate blood concentration of anticoagulants and reduce the risk of adverse events, anticoagulation monitoring is crucial. In contrast, due to contact of blood with artificial surfaces, some patients develop hyperinflammation which may increase the risk of thrombosis.
Patients undergoing heart surgery require full heparinization before the start of the heart-lung machine, which is later reversed using protamine. The levels of anticoagulation are intraoperatively monitored with activated clotting time (ACT). In the postoperative period, the monitoring of rest-heparinization or rebound effect is further performed. In certain cases, the addition of protamine is needed, based on the available monitoring tests. The postoperative monitoring of anticoagulation is usually performed using ACT and activated partial thromboplastin time (aPTT), and may be extended by other diagnostic methods, including viscoelastic tests. Moreover, to ensure the hemostatic capacity of the patient, monitoring of other parameters (platelet count, fibrinogen concentration, prothrombin time quick assay (PT), antithrombin level, etc.) may be included. Finally, in the case of patients receiving extracorporeal life support (ECMO), continuous anticoagulation is indicated, and its monitoring is of immense importance.
Furthermore, in the case of vascular surgery, patients require unfractionated heparin (UFH) intraoperatively, including postoperative continuous infusion.
The evidence on correlation and available monitoring tools is scarce and contradictory, usually based on retrospective analyses of patients´ data from medical charts. Additionally, the role of inflammation in the development of delirium is still unclear, and this association is a subject of debate.
Well-known consequences of postoperative delirium (POD) include poor functional outcome with increased morbidity and mortality, and increased healthcare costs due to institutionalization and rehospitalization. The incidence of POD after cardiac and vascular surgery remains between 13 and 52%. The current hypothesis on the pathophysiology of POD includes disruption of the blood-brain barrier allowing peripheral inflammation and mediators to cause neuro-inflammation. Neurotoxicity induced by a disbalance of pro- and anti-inflammatory mediators and oxidative stress might explain neuronal damage and neurotransmitter disbalance responsible for POD. To improve patients´ functional outcome and the financial burden of POD there is a growing interest in identifying predictive and diagnostic (bio-)markers. The neurofilament light chain (NfL) protein has shown promising results as a potential biomarker for POD. However, the literature on cardiac and vascular patients is limited.
- Conditions
- Heart Surgery, Vascular Surgery, Delirium, Hyperinflammatory Syndrome
- Being tested
- Anticoagulation monitoring
- Keywords
- cardiac surgery, vascular surgery, Anticoagulation, Adverse Events, Monitoring, Delirium, Inflammation
- Medical subject headings
- Delirium, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation monitoringDiagnostic test
Evaluation of different monitoring modalities to find the most appropriate anticoagulation monitoring tool for UFH therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients after cardiovascular surgery who received anticoagulation | The investigated population comprises all patients after cardiovascular surgery who received anticoagulation. Subgroup analyses based on the level of inflammation, delirium, anticoagulation, and others will be conducted. Receives: Diagnostic Test: Anticoagulation monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events occurence
Occurence of adverse events associated with anticoagulation monitoring and hyperinflammation
Measured: Patient follow-up of maximum 30 days
Secondary outcomes (6)
ACT, aPTT, ROTEM, anti-factor Xa: Specific measured anticoagulation levels associated with adverse events
Correlation and thresholds associated with adverse events
Measured: Patient follow-up of maximum 30 days
Correlation of each anticoagulation monitoring test with another (ACT, aPTT, ROTEM, anti-F-Xa)
Correlation between various tests
Measured: Patient follow-up of maximum 30 days
Incidence of UFH-rebound and the need for protamine application
The rate of UFH-rebound
Measured: Patient follow-up of maximum 30 days
Anticoagulation needs for patients receiving ECMO support and experiencing inflammation
Anticoagulation range for patients with inflammation
Measured: Patient follow-up of maximum 30 days
Association of significant inflammation with adverse events
Impact of inflammation on adverse events occurence
Measured: Patient follow-up of maximum 30 days
Incidence of ECMO support and delirium
The rate of delirium, and the ECMO rate in patients after cardiovascular surgery
Measured: Patient follow-up of maximum 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start25 Jun 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222866
- Sponsor's protocol ID
- PAC-AIM
- Acronym
- PAC-AIM
- Status last verified
- Nov 2024
- First submitted
- 15 Jan 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision will be made
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06222866
- Acronym / sponsor ID
- PAC-AIM / PAC-AIM
- Conditions
- Heart Surgery, Vascular Surgery, Delirium, Hyperinflammatory Syndrome
- Keywords
- cardiac surgery, vascular surgery, Anticoagulation, Adverse Events, Monitoring, Delirium, Inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 25 Jan 2024 (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.
The goal of this prospective observational study is to evaluate the most appropriate anticoagulation monitoring tool for unfractionated heparin (UFH), by comparison of different monitoring modalities in relation to adverse events occurrence (thrombosis/bleeding).
The main study questions are:
- What is the most appropriate anticoagulation monitoring tool (ACT, aPTT, viscoelastic tests (ROTEM), and anti-Xa) for UFH
- What is the incidence of adverse events associated with anticoagulation and inflammation after heart and vascular interventions
- Is there an association of available anticoagulation thresholds and monitoring tests with bleeding and/or thrombosis occurrence
- Is there an association of inflammation with delirium
Secondary study objectives include:
- Association of anticoagulation levels as measured by ACT, aPTT, viscoelastic tests (ROTEM), and anti-factor-Xa with adverse events
- Correlation of each anticoagulation monitoring test with the UFH anti-Xa measurement
- Correlation of each anticoagulation monitoring test with another (ACT, aPTT, ROTEM, anti-F-Xa) and the amount of blood loss post surgery
- The incidence of UFH-rebound effect and the need for protamine application
- Association of inflammation and increased / reduced need for anticoagulation titration
- Correlation of anticoagulation dosing with anticoagulation monitoring tests and adverse events
- The association of inflammation with adverse events
- The association and impact of inflammation on measured levels of anticoagulation with available tests
- Influence of anticoagulation on mortality
- Incidence of ECMO support
- Incidence of delirium (hypoactive and hyperactive) and correlation with vital (newly onset postoperative atrial fibrillation amongst others) and laboratory parameters, including, and pre-existing neurological disorders
Detailed description
Patients undergoing major heart and vascular surgery are often in need of intraoperative and/or postoperative anticoagulation. To ensure the appropriate blood concentration of anticoagulants and reduce the risk of adverse events, anticoagulation monitoring is crucial. In contrast, due to contact of blood with artificial surfaces, some patients develop hyperinflammation which may increase the risk of thrombosis.
Patients undergoing heart surgery require full heparinization before the start of the heart-lung machine, which is later reversed using protamine. The levels of anticoagulation are intraoperatively monitored with activated clotting time (ACT). In the postoperative period, the monitoring of rest-heparinization or rebound effect is further performed. In certain cases, the addition of protamine is needed, based on the available monitoring tests. The postoperative monitoring of anticoagulation is usually performed using ACT and activated partial thromboplastin time (aPTT), and may be extended by other diagnostic methods, including viscoelastic tests. Moreover, to ensure the hemostatic capacity of the patient, monitoring of other parameters (platelet count, fibrinogen concentration, prothrombin time quick assay (PT), antithrombin level, etc.) may be included. Finally, in the case of patients receiving extracorporeal life support (ECMO), continuous anticoagulation is indicated, and its monitoring is of immense importance.
Furthermore, in the case of vascular surgery, patients require unfractionated heparin (UFH) intraoperatively, including postoperative continuous infusion.
The evidence on correlation and available monitoring tools is scarce and contradictory, usually based on retrospective analyses of patients´ data from medical charts. Additionally, the role of inflammation in the development of delirium is still unclear, and this association is a subject of debate.
Well-known consequences of postoperative delirium (POD) include poor functional outcome with increased morbidity and mortality, and increased healthcare costs due to institutionalization and rehospitalization. The incidence of POD after cardiac and vascular surgery remains between 13 and 52%. The current hypothesis on the pathophysiology of POD includes disruption of the blood-brain barrier allowing peripheral inflammation and mediators to cause neuro-inflammation. Neurotoxicity induced by a disbalance of pro- and anti-inflammatory mediators and oxidative stress might explain neuronal damage and neurotransmitter disbalance responsible for POD. To improve patients´ functional outcome and the financial burden of POD there is a growing interest in identifying predictive and diagnostic (bio-)markers. The neurofilament light chain (NfL) protein has shown promising results as a potential biomarker for POD. However, the literature on cardiac and vascular patients is limited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after cardiovascular surgery who received anticoagulation | – | Diagnostic Test: Anticoagulation monitoringThe investigated population comprises all patients after cardiovascular surgery who received anticoagulation. Subgroup analyses based on the level of inflammation, delirium, anticoagulation, and others will be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients needing cardiac or vascular surgery who receive anticoagulation
Key inclusion criteria (5 listed)
- Age: > 17 years
- Informed written consent
- Scheduled for cardiac intervention where the use of UFH is expected (elective surgery)
- Scheduled for vascular intervention when the need for perioperative anticoagulation is expected (elective surgery)
- Patients receiving ECMO support
Key exclusion criteria (2 listed)
- Patients that are known to be pregnant
- Known participation in other interventional clinical trial
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 |
|---|---|---|
| Anticoagulation monitoringEvaluation of different monitoring modalities to find the most appropriate anticoagulation monitoring tool for UFH therapy | Diagnostic test | Patients after cardiovascular surgery who received anticoagulation |
Primary outcome
Adverse events occurence
Time frame: Patient follow-up of maximum 30 days
Occurence of adverse events associated with anticoagulation monitoring and hyperinflammation
6 secondary outcomes
ACT, aPTT, ROTEM, anti-factor Xa: Specific measured anticoagulation levels associated with adverse events
Time frame: Patient follow-up of maximum 30 days
Correlation of each anticoagulation monitoring test with another (ACT, aPTT, ROTEM, anti-F-Xa)
Time frame: Patient follow-up of maximum 30 days
Incidence of UFH-rebound and the need for protamine application
Time frame: Patient follow-up of maximum 30 days
Anticoagulation needs for patients receiving ECMO support and experiencing inflammation
Time frame: Patient follow-up of maximum 30 days
Association of significant inflammation with adverse events
Time frame: Patient follow-up of maximum 30 days
Incidence of ECMO support and delirium
Time frame: Patient follow-up of maximum 30 days
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 26 Nov 2024.
- Individual participant dataSharing planned: Undecided. The decision will be made
Related trials for Heart Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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.
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 Heart Surgery and Vascular Surgery, run by Medical University Innsbruck at 1 site in Austria.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Nov 2024. 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 Austria. 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?
Contact Sasa Rajsic, MD, PhD (004367763004447, sasa.rajsic@tirol-kliniken.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events occurence (time frame: Patient follow-up of maximum 30 days). 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 26 Nov 2024.