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Clotting Medication for Major Bleeding
Study Summary
This trial is testing a new clotting medication to see if it is effective and safe in patients who are taking a blood thinner and have major bleeding.
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.Side effects data
From 2022 Phase 3 trial • 208 Patients • NCT02740335Trial Design
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Who is running the clinical trial?
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- I have had a heart attack, stroke, or blood clot in the last 3 months.I took certain blood-thinning medications before my recent bleeding event.My acute trauma cannot be managed by reversing DOAC therapy with factor Xa inhibitor alone.I have not had blood clotting disorders like DIC in the last 3 months.I have a hereditary bleeding disorder.I am scheduled for surgery within the next 12 hours.I am taking blood thinners and my baseline anti-factor Xa activity is at least 100 ng/mL.I am 18 years old or older.I have received treatment to stop bleeding before joining this study.I am taking enoxaparin for blood clot prevention.I am currently experiencing severe bleeding.My brain function score is low, or I have a large brain bleed.
- Group 1: Octaplex Low-dose
- Group 2: Octaplex High-dose
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 Octaplex been cleared by the FDA for use in patients?
"Octaplex is considered safe based on our 3-point scale. This medication has completed Phase 3 clinical trials, meaning that there is evidence of both efficacy and safety from multiple rounds of testing."
Are there any open vacancies for this clinical trial?
"The study is still recruiting patients, as noted by the most recent update on clinicaltrials.gov (11/4/2022). It was originally posted on September 1st, 2021."
Are there any other locations in the state where this trial is taking place?
"OHSU in Portland, Oregon; HCMC in Minneapolis, Minnesota; UMMC in Jackson, Mississippi are a few of the hospitals conducting this clinical trial - with 6 other locations also participating."
Is this research project the first to explore this specific treatment?
"Octaplex has been the focus of medical research since 2018. After an initial trial, which was sponsored by CSL Behring and included 60 patients, Octaplex received Phase 3 drug approval in 2018. Currently, there are six ongoing studies involving Octaplex across 36 cities in eight countries."
What blood conditions does Octaplex typically help to improve?
"While octaplex is most often used to prevent perioperative bleeding for patients with factor x deficiency, it can also be given as a treatment for other issues like severe congenital protein c deficiency, abetalipoproteinemia, and excessive bleeding."
What is the Octaplex clinical trial history?
"UPMC Presbyterian Shadyside published the first study on Octaplex in 2018. As of now, there have been 74 completed clinical trials and 6 that are ongoing. Most of these recent studies are taking place in Portland, Oregon."
How many people are being asked to participate in this test?
"In order to commence this study, the research team needs 200 participants that meet the pre-specified inclusion criteria. Currently, there are two locations where patients can take part in this trial: Oregon Health & Science University and Hennepin County Medical Center."
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