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Study Summary
This trial will study whether different doses of anticoagulants given to patients during cardiac catheterization affects the rate of thrombotic complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I need medication to prevent blood clots.A small-sized tube is used.My hand's blood flow is normal.I have had surgery near the area where they plan to access my body for the trial.I have had a heart catheterization test.I have had an urgent heart catheterization procedure.You have abnormal blood flow in your hands.I have had a blood clot in the artery of my wrist before.You have had heparin-induced thrombocytopenia or are allergic to heparin.
- Group 1: Low dose heparin
- Group 2: High dose heparin
- Group 3: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Has this type of clinical trial been done before?
"Low dose heparin has been researched since 2006, when the first trial was sponsored by Ash Access Technology. That clinical study involved 415 patients and after its success, Low Dose Heparin received Phase 3 drug approval. Now, there are 45 active trials involving this medication taking place in 211 cities and 23 countries around the world."
Is it true that Low dose heparin has a lot of potential side effects?
"There is prior clinical data supporting Low dose heparin's safety, so it received a score of 3."
Are there any available positions for participants in this clinical trial?
"The most recent information from clinicaltrials.gov suggests that this study is still enrolling patients. The listing was first created on October 5th, 2020 and updated on the 6th of the same month."
How many people are being recruited for this clinical trial?
"The latest information from clinicaltrials.gov suggests that this study is still looking for participants. The trial was first announced on October 5th, 2020 and recruitment has been ongoing since then. At the moment, there are 3600 open spots for patients at 2 different hospitals."
How effective has low dose heparin been in other research trials?
"Currently, there are 45 ongoing clinical trials researching Low dose heparin. These medical studies are taking place at 15 different Phase 3 locations and 389 sites in total. The majority of these trials for Low dose heparin are being conducted in Sherbrooke, Quebec."
What are we hoping to learn from conducting this research?
"The primary goal of this one-hour clinical trial is to reduce hematoma size. Additionally, the study will track and collect data secondary objectives including access site bleeding (any bleeding), access site complications (such as pseudoaneurysm, arteriovenous fistula), and time to discharge (defined as when patient leaves post procedure care area)."
What conditions is low-dose heparin treatment often used to address?
"Low dose heparin is frequently used to treat patients with medical devices. It can also be given to those suffering from atrial fibrillation, unstable angina pectoris, and sprains."
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