Anaesthesiologic Considerations for Intraoperative ECMO Anticoagulation During Lung Transplantation

NCT06054997 | Completed

• 1 other identifier: LUTX-UFH
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Transplantation

Keywords

ECMO; Lung transplantation; heparin; UFH; ROTEM; anticoagulation; anesthesiology; bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Outcome Measure the consumption of blood derivatives

  intraoperative

• Outcome Measure surgical revision for postoperative bleeding

  From enrollment to 90-day

• Outcome Measure thrombotic complications

  intraoperative

• Outcome Measure 30-day and 90-day mortality

  From enrollment to 90-day

Study Arms (2)

lower dose UFH/kg group

UFH below or equal to 60 IU/kg/surgery

higher dose UFH/kg group

UFH above 60 IU/kg/surgery

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

All lung transplants between January 2020 and December 2022 within the Prague Lung Transplant Program Motol University Hospital.

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

University Hospital in Motol

Prague, 15006, Czechia

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaromir Vajter, Dr., MD

  University Hospital in Motol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ECLS Center, Principal Investigator

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 26, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: August 1, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)