Heart FailurePhase 3RATENCT04536272
Reduced Anticoagulation Targets in ECLS (RATE)
A Phase 3 study testing Heparin and LMWH in people with Heart Failure and Respiratory Failure, run by University Medical Center Groningen at 8 sites in Netherlands.
Trial summary
The objective of the RATE-trial is to study if reduced anticoagulation targets during ECLS diminish bleeding complications without an increase in thromboembolic complications or a negative impact on outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Respiratory Failure, Extracorporeal Membrane Oxygenation
- What is being tested?
- Heparin and LMWH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 8 sitesNetherlands
- Study dates
- 1 Oct 2020to 7 Mar 2025
- Phase
- Phase 3
- 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
- ECMO treatment during the study period in one of the participating centers
- Age above 18 years
- Written informed consent
Who cannot join
- Patients in whom the ECMO is only used to bridge a procedure
- Vital indication for robust anticoagulation (e.g. mechanic valve, pulmonary embolism)
- History of heparin induced thrombocytopenia
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites
OLVG, location East
Amsterdam, North Holland, 1091AC
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1100DD
University Medical Center Groningen
Groningen, Provincie Groningen, 9700RB
Leids Universitair Medisch Centrum
Leiden, South Holland, 2300RC
Maastricht Universitair Medisch Centrum+
Maastricht, Limburg, 6229HX
Radboud UMC
Nijmegen, Gelderland, 6525GA
Erasmus MC
Rotterdam, South Holland, 3000CA
Isala Clinics
Zwolle, Overijssel, 8025AB
About this study
The objective of the RATE-trial is to study if reduced anticoagulation targets during ECLS diminish bleeding complications without an increase in thromboembolic complications or a negative impact on outcome.
Read the detailed description
Rationale: ECMO treatment has a mortality of 38%, for a large part treatment related due to complications. The most feared complication is ischemic stroke for which heparin is administered with an aPTT target 2.0-2.5 times baseline (approximately 60-75 sec).
However, there is no relation between aPTT and the occurrence of stroke (1.2%), but there is a relation with the much more frequent occurrence of bleeding complications (55%) and blood transfusion. Both are strongly related to outcome.
Objective: Our objective is to study if reduced anticoagulation targets diminish bleeding complications without an increase in thromboembolic complications or a negative impact on outcome.
Study design: Three-arm non-inferiority RCT.
Study population: All adult Dutch patients treated with ECMO during the 30 months of the study.
Intervention: Randomization between heparin administration with a target of 2-2.5 times baseline aPTT (usual care, about 60-75 sec.), 1.5-2.0 times baseline aPTT (45-60 sec.) or low molecular weight heparin (LMWH) guided by weight and renal function.
Main study parameters/endpoints: The primary outcome parameter is a combined endpoint consisting of: 1) major bleeding including hemorrhagic stroke according to the ELSO definitions; 2) severe thromboembolic complication defined as ischemic stroke, limb ischemia (not related with distal perfusion catheter), or acute pump failure with emergency exchange; 3) mortality at 6 months.
Secondary outcome parameters are: 1) blood transfusions; 2) health related quality of life (HR-QoL) at 6 months; 3) exchange of the membrane oxygenator; 4) vessel thrombosis after ECMO removal detected by echography; 5) pulmonary embolism; 6) costs; 7) the individual components of the composite outcome; and 8) all thromboembolic complications combined.
Expected outcomes: We expect that with a target of 1.5-2.0x baseline aPTT or with LMWH the primary composite endpoint will be reached in 60% of patients compared to 70% in usual care. To show non-inferiority with a significance level (alpha) of 5%, power of 80% and a non-inferiority limit (delta) of 7.5% the corresponding sample size is 91 patients per group. In other words, if there is a true difference in favor of the experimental treatment of 10%, then 91 patients per group are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference in favor of the standard group of more than 7.5%. To compensate for a lower effect and drop-outs 330 patients will be enrolled. Apart from anticoagulation targets, treatment will be as usual so study participation will not lead to a burden for the patient, e.g. no extra blood sampling, tests or visits. After 6 months the patients will be contacted for a short questionnaire to measure health-related quality of life.
- Conditions
- Heart Failure, Respiratory Failure, Extracorporeal Membrane Oxygenation, Bleeding, Thrombosis
- Being tested
- Heparin, LMWH
- Keywords
- Extracorporeal membrane oxygenation, Extracorporeal life support, ECMO, ECLS, Anticoagulation, Complications
- Medical subject headings
- Heart Failure, Respiratory Insufficiency, Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Also called Unfractionated heparin
Administration of heparin with a target of 2-2.5 or 1.5-2.0 times baseline aPTT during ECLS.
LMWHDrug
Also called Dalteparine, Enoxaparine, Nadroparine, Tinzaparine
Administration of LMWH guided by weight and renal function during ECLS.
| Study group | Role | What they receive |
|---|---|---|
| Target of 2-2.5 times baseline aPTT (usual care, about 60-75) | Active comparator | Administration of heparin during ECLS with an aPTT target of 2-2.5 times baseline. Receives: Drug: Heparin |
| Target of 1.5-2.0 times baseline aPTT (45-60 sec.) | Active comparator | Administration of heparin during ECLS with an aPTT target of 1.5-2.0 times baseline. Receives: Drug: Heparin |
| LMWH guided by weight and renal function. | Active comparator | Administration of LMWH guided by weight and renal function during ECLS. Receives: Drug: LMWH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhagic complications
Severe hemorrhagic complications will be registered according to the Extracorporeal Life Support Organization (ELSO) definitions for major bleeding and is defined as clinically overt bleeding with a decrease in hemoglobin of at least 1,24 mmol/L (2 g/dl)/24 hours, or a transfusion requirement of ≥ 3 EH RBC over that same time period. Bleeding that is retroperitoneal, pulmonary or involves the central nervous system, or bleeding that requires surgical intervention is also considered major bleeding.
Measured: Through ECLS completion, an average of 14 days
Severe thromboembolic complications
Severe thromboembolic complication defined as ischemic stroke, limb ischemia, or acute pump failure
Measured: Through ECLS completion, an average of 14 days
Mortality
Mortality at 6 months
Measured: 6 months after ECLS
Secondary outcomes (7)
Number of blood transfusions
Number of blood transfusions during ECLS
Measured: Through ECLS completion, an average of 14 days
Quality of life at 6 months
Quality of life (HR-QoL) measured 6 months after decannulation from ECMO
Measured: 6 months after ECLS
Exchange of the membrane oxygenator
Number of echanges of the membrane oxygenator during ECLS
Measured: Through ECLS completion, an average of 14 days
Vessel thrombosis after ECLS removal
Vessel thrombosis after ECLS removal detected by echography
Measured: After ECLS completion, an average of 14 days
Cost- effectiveness
Cost- effectiveness will be based on reduced costs of blood transfusions and interventions for bleeding (e.g. surgery, interventional radiology) as well as improved outcome. All medical cost items expected to be affected by the ECMO therapy will be measured and valued according to the Dutch standard guidelines for economic evaluations, e.g. blood transfusion, number of ECMO replacements, surgery, and hospital length of stay.
Measured: 6 months after ECLS
Pulmonary embolism
The occurrence of Pulmonary embolism during ECLS
Measured: Through ECLS completion, an average of 14 days
All thromboembolic complications combined
The occurrence of all thromboembolic complications combined during ECLS
Measured: Through ECLS completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Oct 2020
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization between anticoagulation targets during ECLS of: 1). 2-2.5 times baseline aPTT (usual care, about 60-75 sec.), 2). 1.5-2.0 times baseline aPTT (45-60 sec.) or 3). LMWH guided by weight and renal function.
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Erasmus Medical Center, Leiden University Medical Center, St. Antonius Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Isala, OLVG, Radboud University Medical Center
- Responsible party
- Principal investigator, Walter M. van den Bergh, University Medical Center Groningen
- Investigators
- W.M. van den Bergh, PhD, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536272
- Sponsor's protocol ID
- 201900659
- Other IDs
- 848018014, 7969, 2019-004125-24, 2019
- Acronym
- RATE
- Status last verified
- May 2025
- First submitted
- 24 Aug 2020
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Minnen OV, Lansink-Hartgring AO, van Amstel RBE, van den Bogaard B, Bunge JJH, Delnoij TSR, Droogh JM, Koppenhagen LV, Kraemer CVE, Kuijpers M, Maas JJ, Metz J, van de Poll MCG, Raasveld SJ, Dos Reis Miranda D, Vart P, Vermeulen KM, Vlaar APJ, van den Bergh WM; Dutch ECLS Study Group. Standard-dose unfractionated heparin versus low-dose unfractionated heparin and low-molecular-weight heparin in extracorporeal life support (RATE): an open-label, randomised, non-inferiority trial. Lancet. 2026 Jul 25;408(10552):357-366. doi: 10.1016/S0140-6736(26)00851-2. Epub 2026 Jul 7.
PubMed 42413523Vlasma JR, Fan Y, van der Velde P, Metz E, Lansink AO, Hoffmann RF, Nawijn MC, Burgess JK, Pillay J. Myeloid Cell Differentiation Within Extracorporeal Membrane Oxygenators in Patients With Acute Respiratory Distress Syndrome. ASAIO J. 2026 Jun 1;72(6):e89-e91. doi: 10.1097/MAT.0000000000002650. Epub 2026 Jan 13. No abstract available.
PubMed 41527181van Minnen O, Linde M, Oude Lansink-Hartgring A, van den Boogaard B, Bunge JJH, Delnoij TSR, Elzo Kraemer CV, Kuijpers M, Maas JJ, de Metz J, van de Poll M, Dos Reis Miranda D, Vlaar APJ, van Ravenzwaaij D, van den Bergh WM. Reduced anticoagulation targets in extracorporeal life support (RATE): protocol for a pre-planned secondary Bayesian analysis of the rate trial. Trials. 2025 Mar 15;26(1):90. doi: 10.1186/s13063-025-08737-6.
PubMed 40087802van Minnen O, Oude Lansink-Hartgring A, van den Boogaard B, van den Brule J, Bulpa P, Bunge JJH, Delnoij TSR, Elzo Kraemer CV, Kuijpers M, Lambermont B, Maas JJ, de Metz J, Michaux I, van de Pol I, van de Poll M, Raasveld SJ, Raes M, Dos Reis Miranda D, Scholten E, Simonet O, Taccone FS, Vallot F, Vlaar APJ, van den Bergh WM. Reduced anticoagulation targets in extracorporeal life support (RATE): study protocol for a randomized controlled trial. Trials. 2022 May 16;23(1):405. doi: 10.1186/s13063-022-06367-w.
PubMed 35578271
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Anticoagulation Targets in ECLS (RATE)
- ClinicalTrials.gov ID
- NCT04536272
- Acronym / sponsor ID
- RATE / 201900659
- Conditions
- Heart Failure, Respiratory Failure, Extracorporeal Membrane Oxygenation, Bleeding, Thrombosis
- Keywords
- Extracorporeal membrane oxygenation, Extracorporeal life support, ECMO, ECLS, Anticoagulation, Complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Erasmus Medical Center, Leiden University Medical Center, St. Antonius Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Isala, OLVG, Radboud University Medical Center
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 2 Sep 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.
The objective of the RATE-trial is to study if reduced anticoagulation targets during ECLS diminish bleeding complications without an increase in thromboembolic complications or a negative impact on outcome.
Detailed description
Rationale: ECMO treatment has a mortality of 38%, for a large part treatment related due to complications. The most feared complication is ischemic stroke for which heparin is administered with an aPTT target 2.0-2.5 times baseline (approximately 60-75 sec).
However, there is no relation between aPTT and the occurrence of stroke (1.2%), but there is a relation with the much more frequent occurrence of bleeding complications (55%) and blood transfusion. Both are strongly related to outcome.
Objective: Our objective is to study if reduced anticoagulation targets diminish bleeding complications without an increase in thromboembolic complications or a negative impact on outcome.
Study design: Three-arm non-inferiority RCT.
Study population: All adult Dutch patients treated with ECMO during the 30 months of the study.
Intervention: Randomization between heparin administration with a target of 2-2.5 times baseline aPTT (usual care, about 60-75 sec.), 1.5-2.0 times baseline aPTT (45-60 sec.) or low molecular weight heparin (LMWH) guided by weight and renal function.
Main study parameters/endpoints: The primary outcome parameter is a combined endpoint consisting of: 1) major bleeding including hemorrhagic stroke according to the ELSO definitions; 2) severe thromboembolic complication defined as ischemic stroke, limb ischemia (not related with distal perfusion catheter), or acute pump failure with emergency exchange; 3) mortality at 6 months.
Secondary outcome parameters are: 1) blood transfusions; 2) health related quality of life (HR-QoL) at 6 months; 3) exchange of the membrane oxygenator; 4) vessel thrombosis after ECMO removal detected by echography; 5) pulmonary embolism; 6) costs; 7) the individual components of the composite outcome; and 8) all thromboembolic complications combined.
Expected outcomes: We expect that with a target of 1.5-2.0x baseline aPTT or with LMWH the primary composite endpoint will be reached in 60% of patients compared to 70% in usual care. To show non-inferiority with a significance level (alpha) of 5%, power of 80% and a non-inferiority limit (delta) of 7.5% the corresponding sample size is 91 patients per group. In other words, if there is a true difference in favor of the experimental treatment of 10%, then 91 patients per group are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference in favor of the standard group of more than 7.5%. To compensate for a lower effect and drop-outs 330 patients will be enrolled. Apart from anticoagulation targets, treatment will be as usual so study participation will not lead to a burden for the patient, e.g. no extra blood sampling, tests or visits. After 6 months the patients will be contacted for a short questionnaire to measure health-related quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomization between anticoagulation targets during ECLS of: 1). 2-2.5 times baseline aPTT (usual care, about 60-75 sec.), 2). 1.5-2.0 times baseline aPTT (45-60 sec.) or 3). LMWH guided by weight and renal function.
| Arm | Type | Receives |
|---|---|---|
| Target of 2-2.5 times baseline aPTT (usual care, about 60-75) | Active comparator | Drug: HeparinAdministration of heparin during ECLS with an aPTT target of 2-2.5 times baseline. |
| Target of 1.5-2.0 times baseline aPTT (45-60 sec.) | Active comparator | Drug: HeparinAdministration of heparin during ECLS with an aPTT target of 1.5-2.0 times baseline. |
| LMWH guided by weight and renal function. | Active comparator | Drug: LMWHAdministration of LMWH guided by weight and renal function during ECLS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ECMO treatment during the study period in one of the participating centers
- Age above 18 years
- Written informed consent
Key exclusion criteria (3 listed)
- Patients in whom the ECMO is only used to bridge a procedure
- Vital indication for robust anticoagulation (e.g. mechanic valve, pulmonary embolism)
- History of heparin induced thrombocytopenia
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 |
|---|---|---|
| HeparinAlso: Unfractionated heparinAdministration of heparin with a target of 2-2.5 or 1.5-2.0 times baseline aPTT during ECLS. | Drug | Target of 1.5-2.0 times baseline aPTT (45-60 sec.), Target of 2-2.5 times baseline aPTT (usual care, about 60-75) |
| LMWHAlso: Dalteparine, Enoxaparine, Nadroparine, TinzaparineAdministration of LMWH guided by weight and renal function during ECLS. | Drug | LMWH guided by weight and renal function. |
Primary outcome
Hemorrhagic complications
Time frame: Through ECLS completion, an average of 14 days
Severe hemorrhagic complications will be registered according to the Extracorporeal Life Support Organization (ELSO) definitions for major bleeding and is defined as clinically overt bleeding with a decrease in hemoglobin of at least 1,24 mmol/L (2 g/dl)/24 hours, or a transfusion requirement of ≥ 3 EH RBC over that same time period. Bleeding that is retroperitoneal, pulmonary or involves the central nervous system, or bleeding that requires surgical intervention is also considered major bleeding.
Severe thromboembolic complications
Time frame: Through ECLS completion, an average of 14 days
Severe thromboembolic complication defined as ischemic stroke, limb ischemia, or acute pump failure
Mortality
Time frame: 6 months after ECLS
Mortality at 6 months
7 secondary outcomes
Number of blood transfusions
Time frame: Through ECLS completion, an average of 14 days
Quality of life at 6 months
Time frame: 6 months after ECLS
Exchange of the membrane oxygenator
Time frame: Through ECLS completion, an average of 14 days
Vessel thrombosis after ECLS removal
Time frame: After ECLS completion, an average of 14 days
Cost- effectiveness
Time frame: 6 months after ECLS
Pulmonary embolism
Time frame: Through ECLS completion, an average of 14 days
All thromboembolic complications combined
Time frame: Through ECLS completion, an average of 14 days
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 2 May 2025.
- Derived from this study: PubMed 42413523Minnen OV, Lansink-Hartgring AO, van Amstel RBE, van den Bogaard B, Bunge JJH, Delnoij TSR, Droogh JM, Koppenhagen LV, Kraemer CVE, Kuijpers M, Maas JJ, Metz J, van de Poll MCG, Raasveld SJ, Dos Reis Miranda D, Vart P, Vermeulen KM, Vlaar APJ, van den Bergh WM; Dutch ECLS Study Group. Standard-dose unfractionated heparin versus low-dose unfractionated heparin and low-molecular-weight heparin in extracorporeal life support (RATE): an open-label, randomised, non-inferiority trial. Lancet. 2026 Jul 25;408(10552):357-366. doi: 10.1016/S0140-6736(26)00851-2. Epub 2026 Jul 7.
- Derived from this study: PubMed 41527181Vlasma JR, Fan Y, van der Velde P, Metz E, Lansink AO, Hoffmann RF, Nawijn MC, Burgess JK, Pillay J. Myeloid Cell Differentiation Within Extracorporeal Membrane Oxygenators in Patients With Acute Respiratory Distress Syndrome. ASAIO J. 2026 Jun 1;72(6):e89-e91. doi: 10.1097/MAT.0000000000002650. Epub 2026 Jan 13. No abstract available.
- Derived from this study: PubMed 40087802van Minnen O, Linde M, Oude Lansink-Hartgring A, van den Boogaard B, Bunge JJH, Delnoij TSR, Elzo Kraemer CV, Kuijpers M, Maas JJ, de Metz J, van de Poll M, Dos Reis Miranda D, Vlaar APJ, van Ravenzwaaij D, van den Bergh WM. Reduced anticoagulation targets in extracorporeal life support (RATE): protocol for a pre-planned secondary Bayesian analysis of the rate trial. Trials. 2025 Mar 15;26(1):90. doi: 10.1186/s13063-025-08737-6.
- Derived from this study: PubMed 35578271van Minnen O, Oude Lansink-Hartgring A, van den Boogaard B, van den Brule J, Bulpa P, Bunge JJH, Delnoij TSR, Elzo Kraemer CV, Kuijpers M, Lambermont B, Maas JJ, de Metz J, Michaux I, van de Pol I, van de Poll M, Raasveld SJ, Raes M, Dos Reis Miranda D, Scholten E, Simonet O, Taccone FS, Vallot F, Vlaar APJ, van den Bergh WM. Reduced anticoagulation targets in extracorporeal life support (RATE): study protocol for a randomized controlled trial. Trials. 2022 May 16;23(1):405. doi: 10.1186/s13063-022-06367-w.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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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.
W.M. van den Bergh, PhD, MD principal investigator
University Medical Center Groningen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heparin and LMWH in people with Heart Failure and Respiratory Failure, run by University Medical Center Groningen at 8 sites in Netherlands.
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 3 inclusion and 3 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 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hemorrhagic complications (time frame: Through ECLS completion, an average of 14 days). 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 NCT04536272, which also lists 4 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 2 May 2025.