AnticoagulationROAR-LTNCT06779162
ROTEM-based Optimization of Anticoagulation Regimens in Lung Transplantation
An observational study of Anticoagulation and Lung Transplantation, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
Extracorporeal membrane oxygenation (ECMO) is now a standard component of intraoperative support during lung transplantation, requiring anticoagulation management, typically with unfractionated heparin (UFH). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anticoagulation, Lung Transplantation, Viscoelastic Properties
- How many people
- 65 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 65 lung transplant cases between December 8, 2022, and July 13, 2024, conducted as part of the Prague Lung Transplant Program.
Who may be able to join
- double lung transplant
- use of intraoperative ECMO
- complete laboratory findings
Who cannot join
- combined heart-lung transplantation
- single-lung transplantation
- lung transplantation without ECMO support
- intraoperative bleeding requiring discontinuation of anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Extracorporeal membrane oxygenation (ECMO) is now a standard component of intraoperative support during lung transplantation, requiring anticoagulation management, typically with unfractionated heparin (UFH). While monitoring methods such as Activated Partial Thromboplastin Time (aPTT), Activated Partial Thromboplastin Time Ratio (aPTTr), Anti-Factor Xa Activity (anti-Xa), and Activated Clotting Time (ACT) are commonly used, a reliable bedside method remains elusive due to the unreliability of ACT at low UFH doses. This study evaluates the correlation among these monitoring methods and investigates the potential of the ROTEM Clotting Time INTEM/HEPTEM ratio (I/Hr) as a bedside alternative.
Read the detailed description
Investigators conducted a comprehensive analysis of all lung transplant cases performed between December 8, 2022, and July 13, 2024, as part of the Prague Lung Transplant Program. This study was designed to assess the feasibility of using the ROTEM Clotting Time INTEM/HEPTEM ratio (I/Hr) as a reliable and practical bedside method for monitoring anticoagulation during lung transplantation procedures supported by extracorporeal membrane oxygenation (ECMO). Inclusion criteria focused on patients who underwent double lung transplantation, required intraoperative ECMO support, and had complete laboratory data available. Based on these parameters, investigators included 65 patients in our analysis.
All enrolled patients received unfractionated heparin (UFH) for anticoagulation management during their lung transplant procedures. Coagulation was closely monitored at three critical time points: preoperatively (using the most recent laboratory results prior to surgery), immediately before ECMO cannulation (following UFH administration but prior to initiating ECMO support), and during the ECMO run (after the reperfusion of the first transplanted lung). To ensure a comprehensive assessment, coagulation status was evaluated using a combination of methods: Activated Partial Thromboplastin Time (aPTT), Activated Partial Thromboplastin Time Ratio (aPTTr), Anti-Factor Xa Activity (anti-Xa), Activated Clotting Time (ACT), and the ROTEM Clotting Time INTEM/HEPTEM ratio (I/Hr).
In all cases, ECMO was initiated using a centrally cannulated approach. The drainage cannula was inserted through the right atrial appendage, while the return cannula was positioned in the ascending aorta. This configuration ensured optimal support and minimized complications during the intraoperative period. Extracorporeal circulation was facilitated using advanced devices, including Rotaflow I and Cardiohelp systems, both equipped with heparin-coated ECMO circuits to enhance biocompatibility and reduce clot formation.
Laboratory analyses of aPTT, aPTTr, and anti-Xa levels were performed in the institution's central laboratory, adhering to standardized methodologies to ensure accuracy and consistency. Bedside monitoring of ACT was carried out using the Werfen - HemoChron® system, which provided real-time feedback on clotting status during the procedure. Additionally, viscoelastic testing was performed to provide a detailed assessment of coagulation dynamics. This was primarily conducted using the Werfen - ROTEM® Sigma device, although the ROTEM® Delta device was employed in instances where the primary system was unavailable.
This study aims to establish the utility of the I/Hr as a novel, reliable, and bedside-appropriate method for anticoagulation monitoring during lung transplantation supported by ECMO. By comparing this approach to established monitoring methods, such as aPTT, anti-Xa, and ACT, investigators hope to identify a more effective strategy that aligns with the unique anticoagulation challenges posed by ECMO support. Investigator's findings could pave the way for standardized and improved anticoagulation protocols in lung transplant patients, ultimately enhancing clinical outcomes.
- Keywords
- Anticoagulation, Lung Transplantation, Rotational Thromboelastometry, ROTEM, UFH, INTEM, HEPTEM, Clotting time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 65 subjects who underwent lung transplantation on ECMO | All 65 subjects received unfractionated heparin (UFH) for anticoagulation. Coagulation assessments were performed preoperatively (the nearest laboratory findings prior to lung transplantation), before ECMO cannulation (laboratory results after administering UFH and prior to ECMO cannulation), and throughout the ECMO run (after reperfusion of the first transplanted lung) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can ROTEM be utilized as a bedside method for managing UFH anticoagulation dosing?
To evaluate the relationship between these monitoring methods: I/Hr, aPTT (s), aPTTr, anti-Xa (IU/mL), ACT (s), and to explore the potential of I/Hr as a bedside alternative to UFH monitoring. Correlations will be calculated between ROTEM parameter I/Hr and each of the following laboratory methods:
I/Hr and aPTT, I/Hr and aPTTr, I/Hr and anti-Xa, I/Hr and ACT.
This approach will assess the strength and consistency of the correlations, providing insights into the feasibility of using I/Hr as a reliable bedside alternative to standard laboratory methods.
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Is there a correlation between I/Hr and aPTT?
As part of UFH anticoagulation therapy monitoring, I/Hr and aPTT (measured in seconds) will be assessed at all defined time points (every 60 minutes of ECMO run).
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Is there a correlation between I/Hr and aPTTr?
As part of UFH anticoagulation therapy monitoring, I/Hr and aPTTr will be assessed at all defined time points (every 60 minutes of ECMO run).
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Is there a correlation between I/Hr and anti-Xa?
As part of UFH anticoagulation therapy monitoring, I/Hr and anti-Xa (measured in IU/mL) will be assessed at all defined time points (every 60 minutes of ECMO run).
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Is there a correlation between I/Hr and ACT?
As part of UFH anticoagulation therapy monitoring, I/Hr and ACT (measured in seconds) will be assessed at all defined time points (every 60 minutes of ECMO run).
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Secondary outcomes (6)
Correlation between the laboratory methods aPTT and aPTTr.
The relationship between aPTT (measured in seconds) and aPTTr will be assessed as part of UFH anticoagulation therapy monitoring at all defined time points (every 60 minutes of ECMO run).
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Correlation between the laboratory methods aPTT and anti-Xa.
The relationship between aPTT (measured in seconds) and anti-Xa (measured in IU/ml) will be assessed as part of UFH anticoagulation therapy monitoring at all defined time points (every 60 minutes of ECMO run).
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Correlation between the laboratory methods aPTT and ACT.
The relationship between aPTT (measured in seconds) and ACT (measured in seconds) will be assessed as part of UFH anticoagulation therapy monitoring at all defined time points (every 60 minutes of ECMO run).
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Correlation between the laboratory methods aPTTr and anti-Xa.
The relationship between aPTTr and anti-Xa (measured IU/ml) will be assessed as part of UFH anticoagulation therapy monitoring at all defined time points (every 60 minutes of ECMO run).
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Correlation between the laboratory methods aPTTr and ACT.
The relationship between aPTTr and ACT (measured in seconds) will be assessed as part of UFH anticoagulation therapy monitoring at all defined time points (every 60 minutes of ECMO run).
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Correlation between the laboratory methods anti-Xa and ACT.
The relationship between anti-Xa (measured in IU/ml) and ACT (measured in seconds) will be assessed as part of UFH anticoagulation therapy monitoring at all defined time points (every 60 minutes of ECMO run).
Measured: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies 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
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaromir Vajter, University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779162
- Sponsor's protocol ID
- ROAR-LT
- Acronym
- ROAR-LT
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROTEM-based Optimization of Anticoagulation Regimens in Lung Transplantation
- ClinicalTrials.gov ID
- NCT06779162
- Acronym / sponsor ID
- ROAR-LT / ROAR-LT
- Keywords
- Anticoagulation, Lung Transplantation, Rotational Thromboelastometry, ROTEM, UFH, INTEM, HEPTEM, Clotting time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 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.
Extracorporeal membrane oxygenation (ECMO) is now a standard component of intraoperative support during lung transplantation, requiring anticoagulation management, typically with unfractionated heparin (UFH). While monitoring methods such as Activated Partial Thromboplastin Time (aPTT), Activated Partial Thromboplastin Time Ratio (aPTTr), Anti-Factor Xa Activity (anti-Xa), and Activated Clotting Time (ACT) are commonly used, a reliable bedside method remains elusive due to the unreliability of ACT at low UFH doses. This study evaluates the correlation among these monitoring methods and investigates the potential of the ROTEM Clotting Time INTEM/HEPTEM ratio (I/Hr) as a bedside alternative.
Detailed description
Investigators conducted a comprehensive analysis of all lung transplant cases performed between December 8, 2022, and July 13, 2024, as part of the Prague Lung Transplant Program. This study was designed to assess the feasibility of using the ROTEM Clotting Time INTEM/HEPTEM ratio (I/Hr) as a reliable and practical bedside method for monitoring anticoagulation during lung transplantation procedures supported by extracorporeal membrane oxygenation (ECMO). Inclusion criteria focused on patients who underwent double lung transplantation, required intraoperative ECMO support, and had complete laboratory data available. Based on these parameters, investigators included 65 patients in our analysis.
All enrolled patients received unfractionated heparin (UFH) for anticoagulation management during their lung transplant procedures. Coagulation was closely monitored at three critical time points: preoperatively (using the most recent laboratory results prior to surgery), immediately before ECMO cannulation (following UFH administration but prior to initiating ECMO support), and during the ECMO run (after the reperfusion of the first transplanted lung). To ensure a comprehensive assessment, coagulation status was evaluated using a combination of methods: Activated Partial Thromboplastin Time (aPTT), Activated Partial Thromboplastin Time Ratio (aPTTr), Anti-Factor Xa Activity (anti-Xa), Activated Clotting Time (ACT), and the ROTEM Clotting Time INTEM/HEPTEM ratio (I/Hr).
In all cases, ECMO was initiated using a centrally cannulated approach. The drainage cannula was inserted through the right atrial appendage, while the return cannula was positioned in the ascending aorta. This configuration ensured optimal support and minimized complications during the intraoperative period. Extracorporeal circulation was facilitated using advanced devices, including Rotaflow I and Cardiohelp systems, both equipped with heparin-coated ECMO circuits to enhance biocompatibility and reduce clot formation.
Laboratory analyses of aPTT, aPTTr, and anti-Xa levels were performed in the institution's central laboratory, adhering to standardized methodologies to ensure accuracy and consistency. Bedside monitoring of ACT was carried out using the Werfen - HemoChron® system, which provided real-time feedback on clotting status during the procedure. Additionally, viscoelastic testing was performed to provide a detailed assessment of coagulation dynamics. This was primarily conducted using the Werfen - ROTEM® Sigma device, although the ROTEM® Delta device was employed in instances where the primary system was unavailable.
This study aims to establish the utility of the I/Hr as a novel, reliable, and bedside-appropriate method for anticoagulation monitoring during lung transplantation supported by ECMO. By comparing this approach to established monitoring methods, such as aPTT, anti-Xa, and ACT, investigators hope to identify a more effective strategy that aligns with the unique anticoagulation challenges posed by ECMO support. Investigator's findings could pave the way for standardized and improved anticoagulation protocols in lung transplant patients, ultimately enhancing clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 65 subjects who underwent lung transplantation on ECMO | – | –All 65 subjects received unfractionated heparin (UFH) for anticoagulation. Coagulation assessments were performed preoperatively (the nearest laboratory findings prior to lung transplantation), before ECMO cannulation (laboratory results after administering UFH and prior to ECMO cannulation), and throughout the ECMO run (after reperfusion of the first transplanted lung) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 65 lung transplant cases between December 8, 2022, and July 13, 2024, conducted as part of the Prague Lung Transplant Program.
Key inclusion criteria (3 listed)
- double lung transplant
- use of intraoperative ECMO
- complete laboratory findings
Key exclusion criteria (4 listed)
- combined heart-lung transplantation
- single-lung transplantation
- lung transplantation without ECMO support
- intraoperative bleeding requiring discontinuation of anticoagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Can ROTEM be utilized as a bedside method for managing UFH anticoagulation dosing?
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
To evaluate the relationship between these monitoring methods: I/Hr, aPTT (s), aPTTr, anti-Xa (IU/mL), ACT (s), and to explore the potential of I/Hr as a bedside alternative to UFH monitoring. Correlations will be calculated between ROTEM parameter I/Hr and each of the following laboratory methods: I/Hr and aPTT, I/Hr and aPTTr, I/Hr and anti-Xa, I/Hr and ACT. This approach will assess the strength and consistency of the correlations, providing insights into the feasibility of using I/Hr as a reliable bedside alternative to standard laboratory methods.
Is there a correlation between I/Hr and aPTT?
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
As part of UFH anticoagulation therapy monitoring, I/Hr and aPTT (measured in seconds) will be assessed at all defined time points (every 60 minutes of ECMO run).
Is there a correlation between I/Hr and aPTTr?
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
As part of UFH anticoagulation therapy monitoring, I/Hr and aPTTr will be assessed at all defined time points (every 60 minutes of ECMO run).
Is there a correlation between I/Hr and anti-Xa?
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
As part of UFH anticoagulation therapy monitoring, I/Hr and anti-Xa (measured in IU/mL) will be assessed at all defined time points (every 60 minutes of ECMO run).
Is there a correlation between I/Hr and ACT?
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
As part of UFH anticoagulation therapy monitoring, I/Hr and ACT (measured in seconds) will be assessed at all defined time points (every 60 minutes of ECMO run).
6 secondary outcomes
Correlation between the laboratory methods aPTT and aPTTr.
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Correlation between the laboratory methods aPTT and anti-Xa.
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Correlation between the laboratory methods aPTT and ACT.
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Correlation between the laboratory methods aPTTr and anti-Xa.
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Correlation between the laboratory methods aPTTr and ACT.
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Correlation between the laboratory methods anti-Xa and ACT.
Time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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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 Anticoagulation and Lung Transplantation, run by University Hospital, Motol at 1 site in Czechia.
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 4 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: finished, as of the sponsor's last update on 16 Jan 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Can ROTEM be utilized as a bedside method for managing UFH anticoagulation dosing? (time frame: From the initiation of general anesthesia at the start of the lung transplant procedure until ECMO decannulation. Laboratory methods will be performed every 60 minutes from anesthesia initiation to ECMO cessation, lasting up to 6 hours.). The study lists 5 primary outcomes in all. 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 16 Jan 2025.