ECMO Primary Hemostasis PathologyNCT04456894
Primary Hemostasis Pathology in Patients on ECMO During Lung Transplantation
An observational study of ECMO Primary Hemostasis Pathology, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
Lung transplantation is a very long and difficult procedure accompanied by a number of possible complications. In the vast majority of cases, the operation itself is performed using the ECMO support, which can negatively affect blood clotting, especially the formation of a platelet blood clot, i.e. primary hemostasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ECMO Primary Hemostasis Pathology
- How many people
- 36 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Nov 2020to 15 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on waiting list for planned lung transplantation procedure. Patients with COPD, cystic fibrosis, interstitial pulmonary fibrosis, primary pulmonary hypertension
Who may be able to join
- All patients undergoing elective bilateral lung transplantation on ECMO
Who cannot join
- patients on dual antiplatelets therapy or patients with vWF disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Importance of Monitoring Primary Hemostasis Pathology in Patients on Extracorporeal Membrane Oxygenation (ECMO) During Lung Transplantation
Lung transplantation is a very long and difficult procedure accompanied by a number of possible complications. In the vast majority of cases, the operation itself is performed using the ECMO support, which can negatively affect blood clotting, especially the formation of a platelet blood clot, i.e. primary hemostasis. Thus, the procedure may be accompanied by considerable blood loss, which amount can subsequently negatively affect the postoperative period. It can be assumed, that precise diagnosis of primary hemostasis disorders and subsequent targeted therapy can reduce blood loss and improve outcome of the patient. However, the role of primary hemostasis has not yet been sufficiently specified in this area. Usually, coagulation functions during surgery, are at our department monitored by using ROTEM tests (assesses clot strength), PFA 200 (assesses primary haemostasis under high shear stress conditions and is very sensitive to vWF deficiency) and ROTEM / platelet (assesses primary haemostasis under "low shear stress" conditions and is very susceptible to platelet dysfunction). Targeted therapy by administering necessary clotting factors is used, if any pathology in these tests is detected. However, it is not known, whether the targeted therapy administered is effective enough in patients during the support of extracorporeal circulation. In our monocentric, prospective, observational study, data from the tests mentioned above will be analyzed, and their correlation with a laboratory examination of VWF levels and activity will be monitored. Based on these data, we will try to determine whether perioperative examination of primary hemostasis during lung transplantation (PFA examination, Rotem / platelet-aggregometry and von Willebrand factor-vWF level) is of clinical significance and whether the diagnosis of hemostasis disorder at this level and subsequent targeted therapy may reduce perioperative blood loss.
Read the detailed description
ECMO is a type of extracorporeal circulation that has experienced a significant increase in use in the last decade as a substitute for lung or heart functions in patients, both perioperatively - especially extensive thoracic surgery procedures such as lung transplantation, or in resuscitation care - in life-threatening conditions associated with heart or lung failure. It uses the classical principle of extracorporeal circulation technology to create continuous, non-pulsating blood flow and, at the same time, its extracorporeal oxygenation. In its two basic configurations, it can only be used to provide respiratory support (veno-venous configuration, VV ECMO), or also cardiac support (veno-arterial configuration, VA ECMO).
Due to the fact that ECMO circuit is an artificial system consisting of cannulas, blood pump and oxygenator itself, the blood is exposed to a huge surface that is not covered by endothelium, thus stimulates the activation of proinflammatory and procoagulant systems. This exposure results in a prothrombotic condition that is associated with a high risk of thrombotic complications. At the same time, however, with this continuous activation of the coagulation cascade, platelets and coagulation factors are depleted, this may lead to an increased risk of bleeding. Pathological shear stress may result in direct binding of VWF (von Willebrand factor) and the platelet GPIIb / IIIa receptor, resulting in their activation and thrombotic complications, however, the effect of non-physiological shear stress may also lead to loss of GPIbα and GPVI platelet receptors, which, in the opposite, causes a disorder of their adhesion and aggregation to VWF and collagen and increases risk of bleeding. Another important factor is loss and fragmentation of the large VWF multimers, a condition known as acquired von Willebrand's syndrome, which causes platelet adhesion to be impaired and thus contributes to bleeding complications.
Both of these situations, definitely, increase morbidity and mortality in patients, so it is necessary to find an optimal and reliable options for the coagulation system functions monitoration, based on which it is possible to immediately perform a targeted therapeutic intervention.
Results of several studies suggest, that increased platelet activation or decreased function results in both thrombotic and bleeding complications in patients requiring extracorporeal support, and these changes cannot be detected by tests, which are usually performed (ROTEM or other common coagulation tests).
Hypothesis:
ECMO causes an early disorder of primary hemostasis, which is detectable by point of care (POC) testing methods PFA 200 and ROTEM / platelet, according to their results, targeted and effective therapy can be applied.
Objectives:
Primary objective is to find out:
- whether ECMO implantation leads to an early failure of primary hemostasis, which can be diagnosed by POC examination - PFA 200, Rotem / platelet-aggregometry and von Willebrand factor levels.
- whether targeted therapy of primary hemostasis disorders (based on the results of POC tests) leads to normalization of these tests results and cessation of bleeding
Secondary objectives:
- to determine the extent of correlation of POC tests of primary hemostasis and laboratory examination of VWF function and quantity
- to clarify the correlation between possible pathological values of these tests and clinically significant bleeding in the patient
- identification of the most reliable method for the assessment of primary hemostasis
Methods:
The group of patients will be represented by patients indicated for implantation of ECMO support during the lung transplantation procedure. ROTEM, PFA 200 and ROTEM / platelet POCs will be used for the perioperative detection of primary and secondary hemostasis disorders- this is a standard approach in Motol University Hospital. In addition to these standard tests, an analysis of the blood sample will also be performed in cooperation with the Institute of hematology and blood transfusion. These tests are represented by quantification of vFW (using quantification of vWF antigen), vFW function test - Ristocetin Cofactor Assay (ex vivo examination of patient's blood plasma, which is depleted of platelets but contains vWF) and Colagen Binding Assay (measures the ability of VWF, especially its large multimers, to bind to collagen).
Blood samples will be taken:
- after induction into general anesthesia
- shortly (15-60 minutes) after ECMO initiation
- shortly (10 minutes) after administration of aimed therapy (vWF or platelets)
- shortly after ECMO explantation (during admission to the ICU, approximatelly 60 minutes after explantation) An informed consent will be signed with the patient prior to lung transplantation.
Time schedule: 1 year (i.e. 40 patients, on average, about 35 patients undergo lung transplantation per year at our department).
- Conditions
- ECMO Primary Hemostasis Pathology
- Keywords
- ECMO, PFA 200, ROTEMplatelets, bleeding
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
To find out whether ECMO implantation leads to an early failure of primary hemostasis, which can be diagnosed by POC examination - PFA 200, Rotem / platelet-aggregometry and von Willebrand factor levels
To compare primary hemostasis before and after ECMO implantation
Measured: 1 year
To find out whether targeted therapy of primary hemostasis disorders (based on the results of POC tests) leads to normalization of these tests results and cessation of bleeding
To evaluate whether aimed therapy based on results of POC tests leads to improvement of test results and bleeding
Measured: 1 year
To find out whether aimed treatment during ECMO will be effective or whether primary hemostasis pathology can be by-passed by activated FVIIa
In case that aimed therapy does not stop bleeding or improved POC tests, activated FVIIa in small dose of 15-30 ug/kg can be used to ,,by-pass" primary hemostasis
Measured: 1 year
Secondary outcomes (2)
To determine the extent of correlation of POC tests of primary hemostasis and laboratory examination of VWF function and quantity
Measured: 1 year
To identify the most reliable method for the assessment of primary hemostasis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start7 Nov 2020
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ECMO Primary Hemostasis PathologyStudies 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
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Durila Miroslav MUDr. Ph.D., University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456894
- Sponsor's protocol ID
- 01072020
- Status last verified
- Feb 2025
- First submitted
- 1 Jul 2020
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lafc G, Budak AB, Yener AU, Cicek OF. Use of extracorporeal membrane oxygenation in adults. Heart Lung Circ. 2014 Jan;23(1):10-23. doi: 10.1016/j.hlc.2013.08.009. Epub 2013 Sep 1.
PubMed 24144910Hayanga JWA, Chan EG, Musgrove K, Leung A, Shigemura N, Hayanga HK. Extracorporeal Membrane Oxygenation in the Perioperative Care of the Lung Transplant Patient. Semin Cardiothorac Vasc Anesth. 2020 Mar;24(1):45-53. doi: 10.1177/1089253219896123. Epub 2020 Jan 2.
PubMed 31893982Chen Z, Mondal NK, Ding J, Koenig SC, Slaughter MS, Wu ZJ. Paradoxical Effect of Nonphysiological Shear Stress on Platelets and von Willebrand Factor. Artif Organs. 2016 Jul;40(7):659-68. doi: 10.1111/aor.12606. Epub 2015 Nov 18.
PubMed 26582038Balle CM, Jeppesen AN, Christensen S, Hvas AM. Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients. Front Cardiovasc Med. 2019 Aug 8;6:114. doi: 10.3389/fcvm.2019.00114. eCollection 2019.
PubMed 31440518Heilmann C, Geisen U, Beyersdorf F, Nakamura L, Benk C, Trummer G, Berchtold-Herz M, Schlensak C, Zieger B. Acquired von Willebrand syndrome in patients with extracorporeal life support (ECLS). Intensive Care Med. 2012 Jan;38(1):62-8. doi: 10.1007/s00134-011-2370-6. Epub 2011 Oct 1.
PubMed 21965100Chen Z, Mondal NK, Zheng S, Koenig SC, Slaughter MS, Griffith BP, Wu ZJ. High shear induces platelet dysfunction leading to enhanced thrombotic propensity and diminished hemostatic capacity. Platelets. 2019;30(1):112-119. doi: 10.1080/09537104.2017.1384542. Epub 2017 Nov 28.
PubMed 29182470Favaloro EJ. Clinical utility of the PFA-100. Semin Thromb Hemost. 2008 Nov;34(8):709-33. doi: 10.1055/s-0029-1145254. Epub 2009 Feb 12.
PubMed 19214910Garaj M, Durila M, Vajter J, Solcova M, Marecek F, Hrachovinova I. Extracorporeal membrane oxygenation seems to induce impairment of primary hemostasis pathology as measured by a Multiplate analyzer: An observational retrospective study. Artif Organs. 2022 May;46(5):899-907. doi: 10.1111/aor.14142. Epub 2021 Dec 17.
PubMed 34904233Durila M, Vajter J, Garaj M, Smetak T, Hedvicak P, Berousek J, Vymazal T. Acquired primary hemostasis pathology detected by platelet function analyzer 200 seen during extracorporeal membrane oxygenation is sufficient to prevent circuit thrombosis: A pilot study. J Heart Lung Transplant. 2020 Sep;39(9):980-982. doi: 10.1016/j.healun.2020.05.015. Epub 2020 Jun 11. No abstract available.
PubMed 32591313Garaj M, Francesconi A, Durila M, Vajter J, Holubova G, Hrachovinova I. ECMO produces very rapid changes in primary hemostasis detected by PFA-200 during lung transplantation: An observational study. J Heart Lung Transplant. 2024 Nov;43(11):1771-1776. doi: 10.1016/j.healun.2024.07.012. Epub 2024 Jul 20.
PubMed 39038564
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Monitoring Primary Hemostasis Pathology in Patients on Extracorporeal Membrane Oxygenation (ECMO) During Lung Transplantation
- ClinicalTrials.gov ID
- NCT04456894
- Acronym / sponsor ID
- 01072020
- Conditions
- ECMO Primary Hemostasis Pathology
- Keywords
- ECMO, PFA 200, ROTEMplatelets, bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 7 Nov 2020 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 7 Jul 2020 (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.
Lung transplantation is a very long and difficult procedure accompanied by a number of possible complications. In the vast majority of cases, the operation itself is performed using the ECMO support, which can negatively affect blood clotting, especially the formation of a platelet blood clot, i.e. primary hemostasis. Thus, the procedure may be accompanied by considerable blood loss, which amount can subsequently negatively affect the postoperative period. It can be assumed, that precise diagnosis of primary hemostasis disorders and subsequent targeted therapy can reduce blood loss and improve outcome of the patient. However, the role of primary hemostasis has not yet been sufficiently specified in this area. Usually, coagulation functions during surgery, are at our department monitored by using ROTEM tests (assesses clot strength), PFA 200 (assesses primary haemostasis under high shear stress conditions and is very sensitive to vWF deficiency) and ROTEM / platelet (assesses primary haemostasis under "low shear stress" conditions and is very susceptible to platelet dysfunction). Targeted therapy by administering necessary clotting factors is used, if any pathology in these tests is detected. However, it is not known, whether the targeted therapy administered is effective enough in patients during the support of extracorporeal circulation. In our monocentric, prospective, observational study, data from the tests mentioned above will be analyzed, and their correlation with a laboratory examination of VWF levels and activity will be monitored. Based on these data, we will try to determine whether perioperative examination of primary hemostasis during lung transplantation (PFA examination, Rotem / platelet-aggregometry and von Willebrand factor-vWF level) is of clinical significance and whether the diagnosis of hemostasis disorder at this level and subsequent targeted therapy may reduce perioperative blood loss.
Detailed description
ECMO is a type of extracorporeal circulation that has experienced a significant increase in use in the last decade as a substitute for lung or heart functions in patients, both perioperatively - especially extensive thoracic surgery procedures such as lung transplantation, or in resuscitation care - in life-threatening conditions associated with heart or lung failure. It uses the classical principle of extracorporeal circulation technology to create continuous, non-pulsating blood flow and, at the same time, its extracorporeal oxygenation. In its two basic configurations, it can only be used to provide respiratory support (veno-venous configuration, VV ECMO), or also cardiac support (veno-arterial configuration, VA ECMO).
Due to the fact that ECMO circuit is an artificial system consisting of cannulas, blood pump and oxygenator itself, the blood is exposed to a huge surface that is not covered by endothelium, thus stimulates the activation of proinflammatory and procoagulant systems. This exposure results in a prothrombotic condition that is associated with a high risk of thrombotic complications. At the same time, however, with this continuous activation of the coagulation cascade, platelets and coagulation factors are depleted, this may lead to an increased risk of bleeding. Pathological shear stress may result in direct binding of VWF (von Willebrand factor) and the platelet GPIIb / IIIa receptor, resulting in their activation and thrombotic complications, however, the effect of non-physiological shear stress may also lead to loss of GPIbα and GPVI platelet receptors, which, in the opposite, causes a disorder of their adhesion and aggregation to VWF and collagen and increases risk of bleeding. Another important factor is loss and fragmentation of the large VWF multimers, a condition known as acquired von Willebrand's syndrome, which causes platelet adhesion to be impaired and thus contributes to bleeding complications.
Both of these situations, definitely, increase morbidity and mortality in patients, so it is necessary to find an optimal and reliable options for the coagulation system functions monitoration, based on which it is possible to immediately perform a targeted therapeutic intervention.
Results of several studies suggest, that increased platelet activation or decreased function results in both thrombotic and bleeding complications in patients requiring extracorporeal support, and these changes cannot be detected by tests, which are usually performed (ROTEM or other common coagulation tests).
Hypothesis:
ECMO causes an early disorder of primary hemostasis, which is detectable by point of care (POC) testing methods PFA 200 and ROTEM / platelet, according to their results, targeted and effective therapy can be applied.
Objectives:
Primary objective is to find out:
- whether ECMO implantation leads to an early failure of primary hemostasis, which can be diagnosed by POC examination - PFA 200, Rotem / platelet-aggregometry and von Willebrand factor levels.
- whether targeted therapy of primary hemostasis disorders (based on the results of POC tests) leads to normalization of these tests results and cessation of bleeding
Secondary objectives:
- to determine the extent of correlation of POC tests of primary hemostasis and laboratory examination of VWF function and quantity
- to clarify the correlation between possible pathological values of these tests and clinically significant bleeding in the patient
- identification of the most reliable method for the assessment of primary hemostasis
Methods:
The group of patients will be represented by patients indicated for implantation of ECMO support during the lung transplantation procedure. ROTEM, PFA 200 and ROTEM / platelet POCs will be used for the perioperative detection of primary and secondary hemostasis disorders- this is a standard approach in Motol University Hospital. In addition to these standard tests, an analysis of the blood sample will also be performed in cooperation with the Institute of hematology and blood transfusion. These tests are represented by quantification of vFW (using quantification of vWF antigen), vFW function test - Ristocetin Cofactor Assay (ex vivo examination of patient's blood plasma, which is depleted of platelets but contains vWF) and Colagen Binding Assay (measures the ability of VWF, especially its large multimers, to bind to collagen).
Blood samples will be taken:
- after induction into general anesthesia
- shortly (15-60 minutes) after ECMO initiation
- shortly (10 minutes) after administration of aimed therapy (vWF or platelets)
- shortly after ECMO explantation (during admission to the ICU, approximatelly 60 minutes after explantation) An informed consent will be signed with the patient prior to lung transplantation.
Time schedule: 1 year (i.e. 40 patients, on average, about 35 patients undergo lung transplantation per year at our department).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on waiting list for planned lung transplantation procedure. Patients with COPD, cystic fibrosis, interstitial pulmonary fibrosis, primary pulmonary hypertension
Key inclusion criteria (1 listed)
- All patients undergoing elective bilateral lung transplantation on ECMO
Key exclusion criteria (1 listed)
- patients on dual antiplatelets therapy or patients with vWF disease
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
To find out whether ECMO implantation leads to an early failure of primary hemostasis, which can be diagnosed by POC examination - PFA 200, Rotem / platelet-aggregometry and von Willebrand factor levels
Time frame: 1 year
To compare primary hemostasis before and after ECMO implantation
To find out whether targeted therapy of primary hemostasis disorders (based on the results of POC tests) leads to normalization of these tests results and cessation of bleeding
Time frame: 1 year
To evaluate whether aimed therapy based on results of POC tests leads to improvement of test results and bleeding
To find out whether aimed treatment during ECMO will be effective or whether primary hemostasis pathology can be by-passed by activated FVIIa
Time frame: 1 year
In case that aimed therapy does not stop bleeding or improved POC tests, activated FVIIa in small dose of 15-30 ug/kg can be used to ,,by-pass" primary hemostasis
2 secondary outcomes
To determine the extent of correlation of POC tests of primary hemostasis and laboratory examination of VWF function and quantity
Time frame: 1 year
To identify the most reliable method for the assessment of primary hemostasis
Time frame: 1 year
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 25 Feb 2025.
- Background: PubMed 24144910Lafc G, Budak AB, Yener AU, Cicek OF. Use of extracorporeal membrane oxygenation in adults. Heart Lung Circ. 2014 Jan;23(1):10-23. doi: 10.1016/j.hlc.2013.08.009. Epub 2013 Sep 1.
- Background: PubMed 31893982Hayanga JWA, Chan EG, Musgrove K, Leung A, Shigemura N, Hayanga HK. Extracorporeal Membrane Oxygenation in the Perioperative Care of the Lung Transplant Patient. Semin Cardiothorac Vasc Anesth. 2020 Mar;24(1):45-53. doi: 10.1177/1089253219896123. Epub 2020 Jan 2.
- Background: PubMed 26582038Chen Z, Mondal NK, Ding J, Koenig SC, Slaughter MS, Wu ZJ. Paradoxical Effect of Nonphysiological Shear Stress on Platelets and von Willebrand Factor. Artif Organs. 2016 Jul;40(7):659-68. doi: 10.1111/aor.12606. Epub 2015 Nov 18.
- Background: PubMed 31440518Balle CM, Jeppesen AN, Christensen S, Hvas AM. Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients. Front Cardiovasc Med. 2019 Aug 8;6:114. doi: 10.3389/fcvm.2019.00114. eCollection 2019.
- Background: PubMed 21965100Heilmann C, Geisen U, Beyersdorf F, Nakamura L, Benk C, Trummer G, Berchtold-Herz M, Schlensak C, Zieger B. Acquired von Willebrand syndrome in patients with extracorporeal life support (ECLS). Intensive Care Med. 2012 Jan;38(1):62-8. doi: 10.1007/s00134-011-2370-6. Epub 2011 Oct 1.
- Background: PubMed 29182470Chen Z, Mondal NK, Zheng S, Koenig SC, Slaughter MS, Griffith BP, Wu ZJ. High shear induces platelet dysfunction leading to enhanced thrombotic propensity and diminished hemostatic capacity. Platelets. 2019;30(1):112-119. doi: 10.1080/09537104.2017.1384542. Epub 2017 Nov 28.
- Background: PubMed 19214910Favaloro EJ. Clinical utility of the PFA-100. Semin Thromb Hemost. 2008 Nov;34(8):709-33. doi: 10.1055/s-0029-1145254. Epub 2009 Feb 12.
- Results publication: PubMed 34904233Garaj M, Durila M, Vajter J, Solcova M, Marecek F, Hrachovinova I. Extracorporeal membrane oxygenation seems to induce impairment of primary hemostasis pathology as measured by a Multiplate analyzer: An observational retrospective study. Artif Organs. 2022 May;46(5):899-907. doi: 10.1111/aor.14142. Epub 2021 Dec 17.
- Results publication: PubMed 32591313Durila M, Vajter J, Garaj M, Smetak T, Hedvicak P, Berousek J, Vymazal T. Acquired primary hemostasis pathology detected by platelet function analyzer 200 seen during extracorporeal membrane oxygenation is sufficient to prevent circuit thrombosis: A pilot study. J Heart Lung Transplant. 2020 Sep;39(9):980-982. doi: 10.1016/j.healun.2020.05.015. Epub 2020 Jun 11. No abstract available.
- Results publication: PubMed 39038564Garaj M, Francesconi A, Durila M, Vajter J, Holubova G, Hrachovinova I. ECMO produces very rapid changes in primary hemostasis detected by PFA-200 during lung transplantation: An observational study. J Heart Lung Transplant. 2024 Nov;43(11):1771-1776. doi: 10.1016/j.healun.2024.07.012. Epub 2024 Jul 20.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 ECMO Primary Hemostasis Pathology, 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 25 Feb 2025. 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?
To find out whether ECMO implantation leads to an early failure of primary hemostasis, which can be diagnosed by POC examination - PFA 200, Rotem / platelet-aggregometry and von Willebrand factor levels (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT04456894, which also lists 10 linked publications.
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 25 Feb 2025.