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Danaparoid Sodium for Heparin Induced Thrombocytopenia (HITSOVA Trial)
HITSOVA Trial Summary
This trial is testing a new drug to see if it is safe and effective in treating people with a certain blood clotting disorder.
- Heparin Induced Thrombocytopenia
HITSOVA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHITSOVA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HITSOVA Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
Are there other scientific papers which mention Danaparoid Sodium?
"Danaparoid Sodium was first trialed in 2019 at the Regional Hospital after N.N Burdenko. There have been a total of 12 completed clinical trials since then, with 5 ongoing studies. A majority of these investigations are taking place in Ottawa, Ontario."
How many staff locations are required to manage this trial?
"This study is enrolling patients at The Ottawa Hospital; 501 Smyth Road in Ottawa, Ontario, Hamilton General Hospital in Hamilton, Ohio, and The Ohio State University Wexner Medical Center in Columbus as well as other sites 9 other locations."
Are there long-term repercussions to taking Danaparoid Sodium?
"Danaparoid Sodium is considered safe based on its status as a Phase 3 clinical trial drug. This classification means that, while there is some efficacy data available, the focus has been on multiple rounds of safety testing."
Has this experiment been attempted before?
"As of right now, there are 5 ongoing studies for Danaparoid Sodium in 94 different cities and 12 nations. The first ever clinical trial occurred in 2019 and was completed by Aspen Global Incorporated. In total, 508 patients were observed during the Phase 3 stage of drug approval. Since that time, an additional 12 trials have been conducted."
Are new patients being accepted into this research project?
"This trial has completed patient recruitment. According to the information on clinicaltrials.gov, The study was posted on 5/16/2019 and updated for the last time on 7/19/2022. There are currently 123 other trials enrolling patients with heparin-induced thrombocytopenia and 5 studies involving Danaparoid Sodium that are actively looking for candidates."
Does this research include young people who are still in their twenties?
"Eligibility for this study begins at 2 weeks old and extends to 100 years of age."
What are the requirements for potential participants of this medical study?
"This trial is looking for 508 participants with heparin-induced thrombocytopenia aged 2 weeks to 100. The most important criteria for applicants are as follows: they must not be a woman of childbearing potential, or a woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and during the entire VKA use and for one month after cessation of its use; subjects should continue with adequate contraception after the study end if they continue with VKA use. (Subjects taking oral contraceptives or hormone replacement therapy must have a stable dose and regimen for ≥ 3 months prior to entry into"
What are the primary indications for Danaparoid Sodium?
"Danaparoid Sodium is a medication used to treat deep vein thrombosis. It can also help prevent deep vein thrombosis caused by orthopedic surgery and percutaneous coronary intervention (pci)."
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