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Lung TransplantationNCT06054997

Anaesthesiologic Considerations for Intraoperative ECMO Anticoagulation During Lung Transplantation

An observational study of Lung Transplantation, run by University Hospital, Motol at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lung Transplantation
How many people
141 participants
Where
1 siteCzechia
Study dates
1 Jan 2020to 1 Aug 2023
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: All lung transplants between January 2020 and December 2022 within the Prague Lung Transplant Program Motol University Hospital.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Czechia1 site
  • University Hospital in Motol

    Prague, 15006

Other trials in Czechia

About this study

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

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.

Read the detailed 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.

Keywords
ECMO, Lung transplantation, heparin, UFH, ROTEM, anticoagulation, anesthesiology, bleeding
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06054997
Study groupRoleWhat they receive
lower dose UFH/kg groupUFH below or equal to 60 IU/kg/surgery
higher dose UFH/kg groupUFH above 60 IU/kg/surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: intraoperative

Secondary outcomes (4)
  1. 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)

    Measured: intraoperative

  2. Outcome Measure surgical revision for postoperative bleeding

    Change in frequency of the surgical revision for postoperative bleeding (From enrollment to 90-day)

    Measured: From enrollment to 90-day

  3. 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)

    Measured: intraoperative

  4. 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)

    Measured: From enrollment to 90-day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2023
  2. Study start1 Jan 2020
  3. Primary completion31 Dec 2022
  4. Study completion1 Aug 2023

Resources

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
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06054997
Sponsor's protocol ID
LUTX-UFH
Status last verified
Sep 2023
First submitted
7 Sep 2023
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No analyzed data are available online. They can be provided after agreement with the principal investigator in case of interest.

Questions about this trial

What is this clinical trial studying?

An observational study of 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 1 inclusion and 1 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 3 Oct 2023. 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?

Outcome Measure intraoperative blood loss (time frame: intraoperative). 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 3 Oct 2023.

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