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Anticoagulant

Danaparoid Sodium for Heparin Induced Thrombocytopenia (HITSOVA Trial)

Phase 3
Waitlist Available
Research Sponsored by Aspen Global Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females aged ≥2 weeks
Signed written informed consent by the subject who is able to assess the nature, significance and scope of the clinical trial. If the subject is in emergency situation and temporarily incapable of consent, the consent of a legal representative or authorized representative will be waived if permitted under applicable local regulations/ethics committee recommendations. Consent must be obtained for further participation in the clinical trial as soon as this is possible and reasonable for the subject to do so to confirm understanding/willingness to participate in the clinical study and ability to comply with study procedures and the study visit schedule.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 44
Awards & highlights

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.

Eligible Conditions
  • Heparin Induced Thrombocytopenia

HITSOVA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

HITSOVA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 44
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 44 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Efficacy Response
Secondary outcome measures
All-cause mortality
Consistent increases in platelet count
Death due to TE or bleeding
+3 more

HITSOVA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Danaparoid SodiumExperimental Treatment1 Intervention
Subjects will receive danaparoid via IV infusion for at least 7 days then transition to a VKA. IV loading bolus injection of 2250 U, followed by 400 U/h for 4 hours, then 300 U/h for 4 hours, then a maintenance infusion of 150-200 U/h.
Group II: ArgatrobanActive Control1 Intervention
Subjects will receive argatroban 2 microgram/kg/min as a continuous infusion, titrated to an aPTT that is 1.5 to 3.0 x initial baseline value, but not exceeding 100 seconds.

Find a Location

Who is running the clinical trial?

Aspen Global IncorporatedLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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)."

Answered by AI
~1 spots leftby Apr 2025