Anaesthesiologic Considerations for Intraoperative ECMO Anticoagulation During Lung Transplantation

Lung Transplantation Clinical Trial

Official title:

Anaesthesiologic Considerations for Intraoperative ECMO Anticoagulation During Lung Transplantation: A Single-centre, Retrospective, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06054997
• Other study ID #: LUTX-UFH
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Extracorporeal membrane oxygenation (ECMO) is a frequently used extracorporeal support measure during the intraoperative period in lung transplantation. A certain amount of anticoagulation, mainly unfractionated heparin (UFH), is used as part of ECMO support. One of the most common perioperative complications during lung transplantation is bleeding. An inadequately high dose of UFH can increase the risk of bleeding. In this study, the investigators hypothesised that a lower dose of UFH would decrease the risk of nonsurgical bleeding complications during lung transplantation and would not pose an increased risk of thrombotic complications for patients or ECMO circuits.

Description:

This study was designed as a single-centre, retrospective, observational study including all lung transplants between January 2020 and December 2022 within the Prague Lung Transplant Program Motol University Hospital. A total of 141 patients were transplanted during the study period. The exclusion criteria were lung transplant without intraoperative ECMO support, block heart-lung transplantation, ECMO bridge to lung transplant and planned postoperative ECMO. The inclusion criteria were lung transplantation performed with intraoperative ECMO support, central ECMO cannulation, and successful ECMO support termination at the end of the surgery. According to the study inclusion criteria, only lung transplants under intraoperative central ECMO cannulation with successful ECMO weaning were included. A total of 109 patients fulfilled the inclusion criteria. Thirty-two patients were excluded based on the following exclusion criteria: heart-lung transplant (HLTx) n=4, ECMO bridge n=4, transplantation (Tx) without ECMO n=8, and planned prolonged ECMO n=16. UFH was used for ECMO anticoagulation in all patients. The subjects were divided into two groups according to the UFH dose during the entire surgical procedure. In the first group, the dose of UFH was below or equal to 60 IU/kg/surgery. In the second group, the dose of UFH was above 60 IU/kg/surgery. A cut-off value of 60 IU/kg was determined according to the available literature review. Values ≤ 60 IU/kg/surgery were considered relatively lower doses, and values > 60 IU/kg/surgery were considered higher doses of UFH. The UFH effect was monitored by activated clotting time (ACT) values. The intraoperative haemoglobin level target for red blood cells (RBCs) substitution was 100 g/l. The parameters that will be monitored intraoperatively in both groups are the total blood loss in millilitres and related to the patient's weight during the operation, the total amount of UFH administered to the patient during the procedure in international units (IU) and related to the patient's weight, and the consumption of blood derivatives during surgery such as red blood cells, fresh frozen plasma (FFP) and platelets. In both groups, ACT values will be monitored after the administration of UFH before ECMO cannulation. In the postoperative period, the investigators will monitor the development of hemothorax requiring surgical revision. The investigators consider surgical revision for hemothorax to be a significant bleeding complication. 30-day and 90-day mortality, ECMO- and patient-related thrombotic complications will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: August 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The inclusion criteria were lung transplantation performed with intraoperative ECMO support, central ECMO cannulation, and successful ECMO support termination at the end of the surgery.

Exclusion Criteria:

• The exclusion criteria were lung transplant without intraoperative ECMO support, block heart-lung transplantation, ECMO bridge to lung transplant and planned postoperative ECMO.

Related Conditions & MeSH terms

• Lung Transplantation

Locations

Country	Name	City	State
Czechia	University Hospital in Motol	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Measure intraoperative blood loss	Change in the amount of intraoperative blood loss (from the start of the surgical procedure till the end of the procedure)	intraoperative
Secondary	Outcome Measure the consumption of blood derivatives	Change in the intraoperative blood derivatives consumption (from the start of the surgical procedure till the end of the procedure)	intraoperative
Secondary	Outcome Measure surgical revision for postoperative bleeding	Change in frequency of the surgical revision for postoperative bleeding (From enrollment to 90-day)	From enrollment to 90-day
Secondary	Outcome Measure thrombotic complications	Change in frequency of the intraoperative thrombotic complications (from the start of the surgical procedure till the end of the procedure)	intraoperative
Secondary	Outcome Measure 30-day and 90-day mortality	Change in 30-day and 90-day mortality (from admission to the ICU until reaching the ninetieth postoperative day)	From enrollment to 90-day