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.
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.
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.
- Conditions
- Lung Transplantation
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
- First posted26 Sep 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies 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
- 141 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
- Investigators
- Jaromir Vajter, Dr., MD, Principal investigator, University Hospital in Motol
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaesthesiologic Considerations for Intraoperative ECMO Anticoagulation During Lung Transplantation: A Single-centre, Retrospective, Observational Study
- ClinicalTrials.gov ID
- NCT06054997
- Acronym / sponsor ID
- LUTX-UFH
- Conditions
- Lung Transplantation
- Keywords
- ECMO, Lung transplantation, heparin, UFH, ROTEM, anticoagulation, anesthesiology, bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 26 Sep 2023 (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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All lung transplants between January 2020 and December 2022 within the Prague Lung Transplant Program Motol University Hospital.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The exclusion criteria were lung transplant without intraoperative ECMO support, block heart-lung transplantation, ECMO bridge to lung transplant and planned postoperative ECMO.
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
Outcome Measure intraoperative blood loss
Time frame: intraoperative
Change in the amount of intraoperative blood loss (from the start of the surgical procedure till the end of the procedure)
4 secondary outcomes
Outcome Measure the consumption of blood derivatives
Time frame: intraoperative
Outcome Measure surgical revision for postoperative bleeding
Time frame: From enrollment to 90-day
Outcome Measure thrombotic complications
Time frame: intraoperative
Outcome Measure 30-day and 90-day mortality
Time frame: From enrollment to 90-day
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 3 Oct 2023.
- Individual participant dataSharing planned: No. No analyzed data are available online. They can be provided after agreement with the principal investigator in case of interest.
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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.
Jaromir Vajter, Dr., MD principal investigator
University Hospital in Motol
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 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.