ROTEM-based Optimization of Anticoagulation Regimens in Lung Transplantation

NCT06779162 | Completed

• 1 other identifier: ROAR-LT
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anticoagulation; Lung Transplantation; Viscoelastic Properties; Unfractionated Heparin

Keywords

Anticoagulation; Lung Transplantation; Rotational Thromboelastometry; ROTEM; UFH; INTEM; HEPTEM; Clotting time

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

Study Arms (1)

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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

65 lung transplant cases between December 8, 2022, and July 13, 2024, conducted as part of the Prague Lung Transplant Program.

You may qualify if:

• double lung transplant
• use of intraoperative ECMO
• complete laboratory findings

You may not qualify if:

• combined heart-lung transplantation
• single-lung transplantation
• lung transplantation without ECMO support
• intraoperative bleeding requiring discontinuation of anticoagulation therapy

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

University Hospital in Motol

Prague, Czech Republic, 15500, Czechia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Extracorporeal Life Support Center

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 16, 2025
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)