Lung TransplantationPhase 4zero-hepNCT05697692
Heparin-free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation
A Phase 4 study testing Heparin sodium in people with Lung Transplantation, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this investigation is to compare two different anti-coagulation strategies in clinical lung transplantation where lung implantations are all routinely done on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) support at the investigators' institution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Heparin sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 20 Dec 2022to 30 Jun 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Double lung transplantation
- Age of 18 or older at the time of the procedure
Who cannot join
- Single lung transplantation
- Re-transplantation
- Previous major thoracic surgery (excluding pleural drainage, video-assisted thoracoscopic - (VATS) biopsy)
- ECMO bridge to transplantation
- Coronavirus(COVID) - acute respiratory distress syndrome (ARDS) as transplant indication
- Pre-operative anti-coagulation/anti-platelet treatment
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- Paediatric transplantation
- Multi-organ transplantation
- Active pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna - Dept. of Thoracic Surgery
Vienna, 1090
Stefan Schwarz, MD PhD, +43 1 40400 ext. 56440, stefan.a.schwarz@meduniwien.ac.at
About this study
Official title: An Investigation of Clinical Outcomes and Inflammatory Response to Heparin Free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation - a Prospective Double-blind Randomised Feasibility Study
The aim of this investigation is to compare two different anti-coagulation strategies in clinical lung transplantation where lung implantations are all routinely done on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) support at the investigators' institution. No heparinization (Zero-Hep) will be compared to standard low-dose heparinization (Standard). Traditionally, the Vienna group has used a standard low-dose heparin protocol with unfractionated heparin (UFH) administered as a bolus upon ECMO cannulation. With heparin-coated tubing and intraoperative ECMO flow never falling below 1 L/min, the likelihood of thromboembolic events is believed to be negligible. To date, the investigators have not experienced any thromboembolic events during intra-operative ECMO use. On the other hand, the use of UFH entails an increased risk for bleeding, so it follows that avoidance of additional heparin may be beneficial. Generally, risks and benefits of heparinization during these short procedures have not yet been thoroughly analyzed. This study will investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response comparing 40 patients receiving a standard dose of heparin versus 40 patients receiving placebo in a randomized, double-blind study design.
- Conditions
- Lung Transplantation
- Being tested
- Heparin sodium, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin sodiumDrug
Lung transplantation on central veno-arterial ECMO with standard additional heparin
PlaceboDrug
Lung transplantation on central veno-arterial ECMO without additional heparin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline 0.9% Receives: Drug: Placebo |
| Heparin sodium | Active comparator | 70 international units (IU)/kg Heparin sodium Receives: Drug: Heparin sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial thromboembolic events
Including myocardial infarction, mesenteric infarction, hepatic infarction, spleen infarction, limb ischemia, cerebral stroke including transient ischemic attack
Measured: From time of intraoperative ECMO initiation, assessed uo to 3 weeks post-transplant
Venous thromboembolic events
deep vein thrombosis, pulmonary embolism, cerebral venous or cavernous sinus thrombosis
Measured: From time of intraoperative ECMO initiation, assessed up to 3 weeks post-transplant
Circuit-related thrombosis
requiring ECMO oxygenator exchange
Measured: From time of intraoperative ECMO initiation assessed until intraoperative ECMO decannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start20 Dec 2022
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Schwarz, Medical University of Vienna
- Investigators
- Konrad Hoetzenecker, MD PhD, Principal investigator, Medical University of Vienna - Dept. of Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697692
- Sponsor's protocol ID
- 2128/2021
- Acronym
- zero-hep
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Clinical Outcomes and Inflammatory Response to Heparin Free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation - a Prospective Double-blind Randomised Feasibility Study
- ClinicalTrials.gov ID
- NCT05697692
- Acronym / sponsor ID
- zero-hep / 2128/2021
- Conditions
- Lung Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Jan 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.
The aim of this investigation is to compare two different anti-coagulation strategies in clinical lung transplantation where lung implantations are all routinely done on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) support at the investigators' institution. No heparinization (Zero-Hep) will be compared to standard low-dose heparinization (Standard). Traditionally, the Vienna group has used a standard low-dose heparin protocol with unfractionated heparin (UFH) administered as a bolus upon ECMO cannulation. With heparin-coated tubing and intraoperative ECMO flow never falling below 1 L/min, the likelihood of thromboembolic events is believed to be negligible. To date, the investigators have not experienced any thromboembolic events during intra-operative ECMO use. On the other hand, the use of UFH entails an increased risk for bleeding, so it follows that avoidance of additional heparin may be beneficial. Generally, risks and benefits of heparinization during these short procedures have not yet been thoroughly analyzed. This study will investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response comparing 40 patients receiving a standard dose of heparin versus 40 patients receiving placebo in a randomized, double-blind study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSaline 0.9% |
| Heparin sodium | Active comparator | Drug: Heparin sodium70 international units (IU)/kg Heparin sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Double lung transplantation
- Age of 18 or older at the time of the procedure
Key exclusion criteria (9 listed)
- Single lung transplantation
- Re-transplantation
- Previous major thoracic surgery (excluding pleural drainage, video-assisted thoracoscopic - (VATS) biopsy)
- ECMO bridge to transplantation
- Coronavirus(COVID) - acute respiratory distress syndrome (ARDS) as transplant indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin sodiumLung transplantation on central veno-arterial ECMO with standard additional heparin | Drug | Heparin sodium |
| PlaceboLung transplantation on central veno-arterial ECMO without additional heparin | Drug | Placebo |
Primary outcome
Arterial thromboembolic events
Time frame: From time of intraoperative ECMO initiation, assessed uo to 3 weeks post-transplant
Including myocardial infarction, mesenteric infarction, hepatic infarction, spleen infarction, limb ischemia, cerebral stroke including transient ischemic attack
Venous thromboembolic events
Time frame: From time of intraoperative ECMO initiation, assessed up to 3 weeks post-transplant
deep vein thrombosis, pulmonary embolism, cerebral venous or cavernous sinus thrombosis
Circuit-related thrombosis
Time frame: From time of intraoperative ECMO initiation assessed until intraoperative ECMO decannulation
requiring ECMO oxygenator exchange
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Konrad Hoetzenecker, MD PhD principal investigator
Medical University of Vienna - Dept. of Thoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparin sodium in people with Lung Transplantation, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Jan 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 Austria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Schwarz, MD PhD (+43 1 40400 ext. 56440, stefan.a.schwarz@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial thromboembolic events (time frame: From time of intraoperative ECMO initiation, assessed uo to 3 weeks post-transplant). The study lists 3 primary outcomes in all. 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 26 Jan 2023.