Extracorporeal Membrane Oxygenation ComplicationPhase 2/3NCT05226442
Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO
A Phase 2/3 study testing Argatroban and Unfractionated heparin in people with Extracorporeal Membrane Oxygenation Complication and Anticoagulants and Bleeding Disorders, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This prospective, randomized, controlled pilot trial aims to assess the safety and feasibility of Argatroban as an alternative anticoagulant to unfractionated heparin in patients receiving extracorporeal membrane oxygenation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Anticoagulants and Bleeding Disorders
- What is being tested?
- Argatroban and Unfractionated heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2021to 7 Jul 2024
- Phase
- Phase 2/3
- 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
- Minimum Age 18 years
- VV- or VA-ECMO therapy
- Minimum of 24h planned ECMO-therapy
Who cannot join
- History of Heparin-induced thrombocytopenia (HIT)
- High risk of bleeding, contraindication for anticoagulation (eg. active GI-bleeding, Intracerebral bleeding; Platelet count <50G/l, congenital bleeding disorder)
- Pregnancy
- Severe Liver disease (SOFA score liver domain 4 points = Bilirubin >12mg/dl)
- Postoperative admission
- Strong lupus anticoagulant or acquired intrinsic clotting factor deficiency at admission (APTT >50 sec without anticoagulation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Pilot Trial on Safety and Feasibility of Argatroban As Anticoagulant in Patients with Extracorporeal Membrane Oxygenation (ECMO)
This prospective, randomized, controlled pilot trial aims to assess the safety and feasibility of Argatroban as an alternative anticoagulant to unfractionated heparin in patients receiving extracorporeal membrane oxygenation.
- Being tested
- Argatroban, Unfractionated heparin
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArgatrobanDrug
Argatroban is a synthetic, univalent DTI, that directly binds to the catalytic thrombin binding site exerting its effects
Unfractionated heparinDrug
Unfractionated heparin produces its major anticoagulant effect by inactivating thrombin and activated factor X (factor Xa) through an antithrombin (AT)-dependent mechanism.
| Study group | Role | What they receive |
|---|---|---|
| Argatroban | Experimental | Continuous infusion of 0,3μg/kg/min to target an aPTT of 50-70sec and/or Hemoclot of 0,60 - 0,80 µg/mL Receives: Drug: Argatroban |
| Unfractionated Heparin | Active comparator | Continuous infusion of Unfractionated Heparin to target an aPTT of 50-60 seconds and/or Anti-Xa level between 0.20 and 0.30 IU/ml and/or thrombin time >20sec. Receives: Drug: Unfractionated heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)
Bleeding will be assessed continuously by the investigators according to the BARC bleeding classification, where bleeding type 2 or higher will be considered as clinically significant bleeding; outcome measures will be the incidence of clinically significant bleeding per ECMO day and time to first bleeding; thrombosis is defined as any occurence of thromboembolism including membrane lung exchange due to suspected thrombosis, pulmonary embolism or deep vein thrombosis; outcome measures will be the incidence of thromboembolism per ECMO day and the time to first thromboembolism
Measured: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
Secondary outcomes (1)
study enrollment, study completion and ability to achieve target values of Argatroban as anticoagulant in ECMO
ratio of screened to included patients, proportion of patients who completed the study according to the protocol, proportion of coagulation tests within range and total number of dose adjustments
Measured: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Dec 2021
- Primary completion7 Jul 2024
- Study completion7 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization ratio of 1:1 for anticoagulation with Argatroban or Unfractionated Heparin
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Staudinger, Medical University of Vienna
- Investigators
- Thomas Staudinger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226442
- Sponsor's protocol ID
- Argatroban_ECMO
- Status last verified
- Sep 2024
- First submitted
- 4 Dec 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Pilot Trial on Safety and Feasibility of Argatroban As Anticoagulant in Patients with Extracorporeal Membrane Oxygenation (ECMO)
- ClinicalTrials.gov ID
- NCT05226442
- Acronym / sponsor ID
- Argatroban_ECMO
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 7 Feb 2022 (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.
This prospective, randomized, controlled pilot trial aims to assess the safety and feasibility of Argatroban as an alternative anticoagulant to unfractionated heparin in patients receiving extracorporeal membrane oxygenation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization ratio of 1:1 for anticoagulation with Argatroban or Unfractionated Heparin
| Arm | Type | Receives |
|---|---|---|
| Argatroban | Experimental | Drug: ArgatrobanContinuous infusion of 0,3μg/kg/min to target an aPTT of 50-70sec and/or Hemoclot of 0,60 - 0,80 µg/mL |
| Unfractionated Heparin | Active comparator | Drug: Unfractionated heparinContinuous infusion of Unfractionated Heparin to target an aPTT of 50-60 seconds and/or Anti-Xa level between 0.20 and 0.30 IU/ml and/or thrombin time >20sec. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Minimum Age 18 years
- VV- or VA-ECMO therapy
- Minimum of 24h planned ECMO-therapy
Key exclusion criteria (6 listed)
- History of Heparin-induced thrombocytopenia (HIT)
- High risk of bleeding, contraindication for anticoagulation (eg. active GI-bleeding, Intracerebral bleeding; Platelet count <50G/l, congenital bleeding disorder)
- Pregnancy
- Severe Liver disease (SOFA score liver domain 4 points = Bilirubin >12mg/dl)
- Postoperative admission
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 |
|---|---|---|
| ArgatrobanArgatroban is a synthetic, univalent DTI, that directly binds to the catalytic thrombin binding site exerting its effects | Drug | Argatroban |
| Unfractionated heparinUnfractionated heparin produces its major anticoagulant effect by inactivating thrombin and activated factor X (factor Xa) through an antithrombin (AT)-dependent mechanism. | Drug | Unfractionated Heparin |
Primary outcome
Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)
Time frame: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
Bleeding will be assessed continuously by the investigators according to the BARC bleeding classification, where bleeding type 2 or higher will be considered as clinically significant bleeding; outcome measures will be the incidence of clinically significant bleeding per ECMO day and time to first bleeding; thrombosis is defined as any occurence of thromboembolism including membrane lung exchange due to suspected thrombosis, pulmonary embolism or deep vein thrombosis; outcome measures will be the incidence of thromboembolism per ECMO day and the time to first thromboembolism
1 secondary outcome
study enrollment, study completion and ability to achieve target values of Argatroban as anticoagulant in ECMO
Time frame: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 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 19 Sep 2024.
- Individual participant dataSharing planned: Yes. upon reasonable request
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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.
Thomas Staudinger, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Argatroban and Unfractionated heparin in people with Extracorporeal Membrane Oxygenation Complication and Anticoagulants and Bleeding Disorders, 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 3 inclusion and 6 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 19 Sep 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH) (time frame: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days). 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 19 Sep 2024.