Low-dose Versus Standard-dose Anticoagulation With Argatroban and Enoxaparin During Extracorporeal Membrane Oxygenation Controlled by Anti-IIa and An-ti-Xa, Respectively
New anticoagulation doses tested for ECMO patients
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 tests if lower doses of specific blood thinners (argatroban and enoxaparin) are safe and effective for patients needing ECMO. It is for adults (18+) who require ECMO support and are not pregnant or breastfeeding. Participation involves receiving either a standard or a lower dose of these blood thinners while on ECMO, with regular monitoring. Current standard treatment uses heparin, but this study explores alternatives to potentially improve outcomes. 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. Adults aged 18 and older who are on ECMO and require blood thinners. Individuals must be willing to provide informed consent. People who are pregnant, breastfeeding, have had lung transplants, or are allergic to the study medications cannot participate. This trial is studying Pneumonia, Heart Failure, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how often patients experience bleeding or blood clots, indicating the safety of the new lower-dose blood thinners. 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 matters because it seeks to find a potentially safer and more effective way to prevent blood clots in critically ill patients on ECMO, addressing a gap in current treatment options. 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
This Phase 2 trial by a university hospital explores novel anticoagulation strategies for ECMO, a critical life support technology, suggesting a focus on improving patient safety and outcomes in a hig Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of low-dose versus standard-dose anticoagulation for your condition. You will receive either a standard or a lower dose of argatroban and enoxaparin while on ECMO, with regular blood tests to monitor its effect. Your progress will be followed for up to 4 weeks on ECMO and for 6 months after, including assessments of your health and quality of life. 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)
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 tests if lower doses of specific blood thinners (argatroban and enoxaparin) are safe and effective for patients needing ECMO. It is for adults (18+) who require ECMO support and are not pregnant or breastfeeding.
Why is this trial significant?
This trial matters because it seeks to find a potentially safer and more effective way to prevent blood clots in critically ill patients on ECMO, addressing a gap in current treatment options.
What are the potential risks of participating in NCT07499037?
The main risks involve bleeding, which could range from minor bruising to more serious internal bleeding. Another risk is the formation of blood clots, which could lead to serious complications like stroke or organ damage. Allergic reactions to the study medications are also possible. 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 the specific risks and benefits of low-dose versus standard-dose anticoagulation for your condition. You will receive either a standard or a lower dose of argatroban and enoxaparin while on ECMO, with regular blood tests to monitor its effect. Your progress will be followed for up to 4 weeks on ECMO and for 6 months after, including assessments of your health and quality of life. 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?
This Phase 2 trial by a university hospital explores novel anticoagulation strategies for ECMO, a critical life support technology, suggesting a focus on improving patient safety and outcomes in a hig 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 a standard or a lower dose of these blood thinners while on ECMO, with regular monitoring. 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.
Related Conditions
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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.