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Catheter-directed Thrombolysis for Pulmonary Embolism (HI-PEITHO Trial)
HI-PEITHO Trial Summary
This trial will compare two ways of treating pulmonary embolism, by either using blood thinners or a device to dissolve blood clots.
HI-PEITHO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHI-PEITHO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HI-PEITHO Trial Design
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Who is running the clinical trial?
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- I haven't had major surgery or serious injury in the last 3 weeks.Your right-to-left ventricular diameter ratio is 1.0 or higher on a specific type of imaging test called a CTPA.I have been treated with dabigatran or edoxaban for my PE without first receiving heparin for 5 days.I have had bleeding in my brain or eyes at some point.I only take low-dose aspirin or clopidogrel for my chronic condition, not both.I have received a clot-dissolving drug or a specific heart medication in the last 30 days.You are not in the intensive care unit for any reason other than the current issue with your lungs. If you have COVID-19, you can join the study if the doctor thinks the main problem is a blood clot in your lungs and your breathing and heart functions are at certain levels.My blood pressure was low but stabilized within 2 hours without needing strong medications.I am currently experiencing active bleeding.I have taken a daily dose of LMWH or fondaparinux within the last 24 hours.I have not had a cardiac arrest or needed CPR recently.I am at high risk of early death or severe health decline due to new health issues.I have had a stroke or mini-stroke in the last 6 months, or any time before that which left me permanently disabled.You need a special machine called ECMO, or you already started using ECMO before joining the study.My symptoms have lasted more than 14 days.Your blood test shows high levels of troponin I or T.Your blood pressure is consistently lower than 110 mm Hg for at least 15 minutes.You have a temperature higher than 102.2 degrees Fahrenheit.Your breathing rate is very high, or your oxygen levels are low even when resting.You are not expected to live for more than 6 months.I am between 18 and 80 years old.I have a brain tumor or cancer that has spread to my brain.Unstable blood pressure or heart rate.I can't quickly get treatments for a lung clot due to an ongoing epidemic.I am on a long-term blood thinner like apixaban or rivaroxaban.You are allergic to alteplase, LMWH, UFH, or any of the ingredients in these medications.Your platelet count is less than 100 billion per liter.I have taken apixaban or rivaroxaban within the last 12 hours.I am on chronic vitamin K treatment or have a blood clotting disorder with an INR > 1.5.I have a confirmed pulmonary embolism shown by a CT scan.I have experienced shock due to a pulmonary embolism, with low blood pressure and signs of poor organ function.Your heart beats too fast, but not because of low blood volume, irregular heartbeats, or infection.
- Group 1: Anticoagulation and EkoSonicTM Endovascular System
- Group 2: Anticoagulation
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What situations necessitate the usage of Anticoagulation?
"Anticoagulation is generally prescribed to treat medical devices, but it can also effectively address issues like sprains, unstable angina pectoris and atrial fibrillation."
What are the geographical coordinates of all sites hosting this experiment?
"Seton Medical Center in Austin, Texas, Nebraska Methodist Hospital in Omaha, Nebraska, and Wellmont Holston Valley Medical Center in Kingsport Tennessee are all hosting this clinical trial. Additionally, it is being conducted at 32 additional sites across the country."
What makes this clinical trial pioneering in comparison to others?
"At present, 36 clinical trials are ongoing concerning anticoagulation across 197 cities and 21 nations. The first investigation of this nature was carried out in 2006 by Ash Access Technology and involved 415 patients, concluding with its Phase 3 drug approval stage. Subsequent to that initial trial, 189 more have been conducted."
What other research projects have studied the effects of Anticoagulation?
"At the moment, 36 studies are underway to investigate anticoagulation. Of those active trails 12 have reached Phase 3 testing and 367 locations around the world are participating in these trials. The majority of research for this treatment is taking place in Sherbrooke, Quebec."
May I join the medical experiment as a volunteer?
"406 volunteers, aged 18 to 80, who have been diagnosed with pulmonary embolism are being recruited for this trial. Additionally, participants must display ECG-documented tachycardia that is not the result of hypovolemia, arrhythmia or sepsis and a heart rate exceeding 100 beats per minute."
What is the cap on the number of individuals included in this experiment?
"This research necessitates the inclusion of 406 participants, that meet all eligibility requirements. From Seton Medical Center in Austin, Texas to Nebraska Methodist Hospital in Omaha, Nebraska - individuals can partake this experiment from numerous locations."
Are participants aged thirty and above eligible for this investigation?
"This clinical trial is enrolling participants who are aged 18 or above and not yet 80."
Is the research team accepting new participants for this experiment?
"Information hosted on clinicaltrials.gov reveals that this trial is still in the process of enrolling participants. The initial posting was made on August 2nd 2021, with a recent update occurring November 15th 2022."
Has the FDA sanctioned Anticoagulation as a safe and effective drug?
"Thanks to the Phase 4 status of this treatment, Anticoagulation has been granted a score of 3 in terms of safety."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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