Low-dose Versus Standard-dose Anticoagulation With Argatroban and Enoxaparin During Extracorporeal Membrane Oxygenation Controlled by Anti-IIa and An-ti-Xa, Respectively
Low-dose Anticoagulation for ECMO: A Phase 2 Trial
Plain English Summary
Safety and Efficacy of Low-dose Anticoagulation With Argatroban and Enoxaparin on ECMO is a Phase 2 clinical trial sponsored by University Hospital Ostrava studying Pneumonia, Heart Failure. This trial compares low-dose and standard-dose anticoagulants (argatroban and enoxaparin) during ECMO to reduce bleeding and clotting risks. It's for patients on ECMO support for pneumonia or heart failure. Participation involves receiving either low-dose or standard-dose anticoagulants during ECMO, with regular monitoring for safety and effectiveness. Alternative treatments include standard heparin therapy based on aPTT levels. The trial aims to enroll 200 participants.
Official Summary
The standard and most common therapy is anticoagulation with heparin according to activated partial thromboplastin time (aPTT) during extracorporeal membrane oxygenation (ECMO) support. The study will focus on evaluating the efficacy and safety of new anticoagulants on ECMO, namely argatroban and enoxaparin in lower doses controlled according to targeted antiIIa and antiXa markers.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible patients must be 18 years or older and undergoing ECMO for pneumonia or heart failure. Excluded are those in the lung transplant program, with known allergies to the study drugs, or who are pregnant or breastfeeding. This trial is studying Pneumonia, Heart Failure, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure the safety of bleeding and clotting during ECMO, which directly impacts patient recovery and reduces the risk of severe complications. The specific primary outcome measures are: Safety of bleeding complications (During ECMO, up to 4 weeks); Safety of thrombotic complications (During ECMO, up to 4 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial aims to fill the gap in safer anticoagulation methods during ECMO, potentially reducing complications and improving patient outcomes. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Pneumonia, Heart Failure, where improved treatment options are needed.
Investor Insight
The market size for ECMO treatments is significant, with a competitive landscape that includes various anticoagulation strategies. The approval probability is moderate given the need for safer alterna Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about your eligibility and the potential benefits and risks of participating in the trial. During the trial, you will receive either low-dose or standard-dose anticoagulants during ECMO, with regular check-ups and monitoring. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 200 participants
Interventions
- DRUG: Low anticoagulation dose of argatroban and enoxaparin during ECMO — Study subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO
- DRUG: Standard anticoagulation dose of argatroban and enoxaparin during ECMO — Study subjects in this group will receive standard anticoagulation dose of argatroban and enoxaparin during ECMO
Primary Outcomes
- Safety of bleeding complications (During ECMO, up to 4 weeks)
- Safety of thrombotic complications (During ECMO, up to 4 weeks)
Secondary Outcomes
- Mortality (6 months)
- Cerebral Performance Category (CPC) score (30 days)
- Quality of Life questionnaires score - EQ-5D-5L (6 months)
- Quality of Life questionnaires score - SF36 (6 months)
Full Eligibility Criteria
Inclusion Criteria: * ECMO support with anticoagulation using argatroban/enoxaparin * Age ≥ 18 years * Obtaining informed consent in accordance with the procedure specified in the protocol Exclusion Criteria: * Enrolment in the lung transplant program at Motol University Hospital * Known hypersensitivity to the components of the evaluated products * Allergic reaction to the active ingredients of the evaluated products * Pregnancy and breastfeeding
Trial Locations
- University Hospital Ostrava, Ostrava, Moravian-Silesian Region, Czechia
- University Hospital Motol, Prague, Czechia
Frequently Asked Questions
What is clinical trial NCT07499037?
NCT07499037 is a Phase 2 INTERVENTIONAL study titled "Safety and Efficacy of Low-dose Anticoagulation With Argatroban and Enoxaparin on ECMO." It is currently not yet recruiting and is sponsored by University Hospital Ostrava. The trial targets enrollment of 200 participants.
What conditions does NCT07499037 study?
This trial investigates treatments for Pneumonia, Heart Failure. The primary condition under study is Pneumonia.
What treatments are being tested in NCT07499037?
The interventions being studied include: Low anticoagulation dose of argatroban and enoxaparin during ECMO (DRUG), Standard anticoagulation dose of argatroban and enoxaparin during ECMO (DRUG). Study subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO
What does Phase 2 mean for NCT07499037?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07499037?
This trial is currently "Not Yet Recruiting." It started on 2027-01. The estimated completion date is 2029-12.
Who is sponsoring NCT07499037?
NCT07499037 is sponsored by University Hospital Ostrava. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07499037?
The trial aims to enroll 200 participants. The trial has not yet started recruiting.
How is NCT07499037 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07499037?
The primary outcome measures are: Safety of bleeding complications (During ECMO, up to 4 weeks); Safety of thrombotic complications (During ECMO, up to 4 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07499037 being conducted?
This trial is being conducted at 2 sites, including Ostrava, Moravian-Silesian Region; Prague (Czechia).
Where can I find official information about NCT07499037?
The official record for NCT07499037 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07499037. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07499037 testing in simple terms?
This trial compares low-dose and standard-dose anticoagulants (argatroban and enoxaparin) during ECMO to reduce bleeding and clotting risks. It's for patients on ECMO support for pneumonia or heart failure.
Why is this trial significant?
This trial aims to fill the gap in safer anticoagulation methods during ECMO, potentially reducing complications and improving patient outcomes.
What are the potential risks of participating in NCT07499037?
Key risks include bleeding and clotting complications, which are monitored closely during the trial. Side effects may include allergic reactions to the study drugs, though these are rare. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07499037?
Ask your doctor about your eligibility and the potential benefits and risks of participating in the trial. During the trial, you will receive either low-dose or standard-dose anticoagulants during ECMO, with regular check-ups and monitoring. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07499037 signal from an investment perspective?
The market size for ECMO treatments is significant, with a competitive landscape that includes various anticoagulation strategies. The approval probability is moderate given the need for safer alterna This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participation involves receiving either low-dose or standard-dose anticoagulants during ECMO, with regular monitoring for safety and effectiveness. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.