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Prothrombin Complex Concentrate

Clotting Medication for Major Bleeding

Phase 3
Recruiting
Research Sponsored by Octapharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients on oral factor Xa inhibitor therapy with known or suspected baseline anti-factor Xa activity of at least 100 ng/mL
Patients aged 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48-hour follow-up period
Awards & highlights

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.

Who is the study for?
Adults (≥18 years) on oral factor Xa inhibitor therapy with acute major bleeding, defined as life-threatening or uncontrolled bleeding, symptomatic critical organ bleeding, or significant drop in hemoglobin. Participants must have anti-factor Xa activity ≥100 ng/mL and provide informed consent. Excluded are those with recent trauma, certain cardiovascular events, coagulation disorders, known hypersensitivity to plasma products, prior use of specific haemostatic agents for the current bleed or participation in another clinical trial within the last month.Check my eligibility
What is being tested?
The study is testing OCTAPLEX's effectiveness and safety at two different doses for patients experiencing severe bleeding while on DOAC therapy with a factor Xa inhibitor. It's a phase 3 trial where participants are randomly assigned to receive either a low-dose or high-dose of OCTAPLEX in an adaptive design that allows modifications based on interim results.See study design
What are the potential side effects?
Potential side effects may include reactions related to blood clotting since OCTAPLEX affects coagulation factors. There could also be allergic reactions due to its plasma-derived nature. Specific side effects will be monitored throughout the trial given its focus on safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am taking blood thinners and my baseline anti-factor Xa activity is at least 100 ng/mL.
Select...
I am 18 years old or older.
Select...
I am currently experiencing severe bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48-hour follow-up period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48-hour follow-up period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemostatic efficacy
Secondary outcome measures
All-cause TEEs and All-cause Mortality
Blood pressure
Body Temperature
+4 more
Other outcome measures
Change in Coagulation Parameters
Change in Hgb
Change in activated partial thromboplastin time (aPTT)
+10 more

Side effects data

From 2022 Phase 3 trial • 208 Patients • NCT02740335
48%
Procedural Pain
14%
Postoperative Wound Complications
12%
Asthenia
6%
Anaemia
6%
Nervous System Disorders
5%
Cardiac AEs
5%
Musculoskeletal and connective tissue disorders
5%
Dysuria
4%
Catheter Site Related Reaction
4%
Procedural Vomiting
4%
Metabolism and nutrition disorders
3%
Abdominal Pain
3%
Hyperthermia
2%
Abdominal Distension
2%
Suture Related Complication
2%
Respiratory, thoracic and mediastinal disorders
1%
Soft Tissue Haemorrhage
1%
Myocardial Ischaemia
1%
Mesenteric Haematoma
1%
Proctitis
1%
Angina Unstable
1%
Cardiac Failure Chronic
1%
Gastritis Erosive
1%
Death
1%
Multiple Organ Dysfunction Syndrome
1%
Orchitis
1%
Anastomotic Haemmorhage
1%
Failure to Anastomose
1%
Joint Dislocation
1%
Subdural Haemorrhage
1%
Cerebral Infarction
1%
Acute Respiratory Failure
1%
Pulmonary Embolism
1%
Pulmonary Oedema
1%
Dyschezia
1%
Pneumonia
1%
Shock
1%
Pyrexia
1%
Vascular Disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octaplex
Beriplex P/N (Kcentra)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Octaplex Low-doseExperimental Treatment1 Intervention
Participants to receive 1 Octaplex infusion intravenously
Group II: Octaplex High-doseExperimental Treatment1 Intervention
Participants to receive 1 Octaplex infusion intravenously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Octaplex
2017
Completed Phase 3
~210

Find a Location

Who is running the clinical trial?

OctapharmaLead Sponsor
83 Previous Clinical Trials
7,474 Total Patients Enrolled
2 Trials studying Bleeding
230 Patients Enrolled for Bleeding

Media Library

Octaplex (Prothrombin Complex Concentrate) Clinical Trial Eligibility Overview. Trial Name: NCT04867837 — Phase 3
Bleeding Research Study Groups: Octaplex Low-dose, Octaplex High-dose
Bleeding Clinical Trial 2023: Octaplex Highlights & Side Effects. Trial Name: NCT04867837 — Phase 3
Octaplex (Prothrombin Complex Concentrate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04867837 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~53 spots leftby Dec 2024