CoagulopathyPhase 2NCT03700723
Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
A Phase 2 study testing Resusix and FP24 (Frozen Plasma) in people with Coagulopathy, run by Entegrion, Inc. at 3 sites in United States.
Trial summary
Phase 2a study to assess the safety and efficacy of IV infused spray-dried solvent/detergent -treated plasma (Resusix) when compared with an equal volume of plasma frozen within 24 hours after phlebotomy (FP24) in patients with liver disease who are actively bleeding or who require prophylaxis for surgical bleeding Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulopathy
- What is being tested?
- Resusix and FP24 (Frozen Plasma)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Dec 2018to 15 Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SBP 90-150 mm Hg
- acquired coagulopathy due to hepatic disease
- INR >1.4
- Order for 1-4 units of plasma for active bleeding or prophylaxis for bleeding prior to surgery or invasive procedure
- Written informed consent
- MELD score: 25 or less (1st cohort), 35 or less (2nd cohort)
Who cannot join
- Pregnant women
- Incarcerated patients
- Life expectancy less than 72 hours
- Severe bleeding at time of enrollment
- HIV, sepsis, intracranial bleeding, congenital disorder, anti-phospholipid antibody syndrome or known lupus anticoagulant antibodies
- Receipt of plasma products, coagulation factor concentrates or anti-platelets within 3 days of enrollment
Show all 13Show fewer
- Specific factor inhibitor activity or history of hypersensitivity to plasma-derived products
- Receipt of iv heparin within 24 hours of enrollment
- Use of a continuous infusion of an intravenous vasoactive medication
- Thrombocytopenia
- BMI greater than or equal to 40 kg/m2
- Participation in another clinical trial within 30 days of enrollment and received investigational product that may impact safety or efficacy of this study
- West Haven Hepatic Encephalopathy Grade 3 or 4 (cohort 1) and Grade 4 (cohort 2)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
Washington University St. Louis
St Louis, Missouri, 63110
University of Arizona
Tucson, Arizona, 85721
About this study
Official title: Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Phase 2a study to assess the safety and efficacy of IV infused spray-dried solvent/detergent -treated plasma (Resusix) when compared with an equal volume of plasma frozen within 24 hours after phlebotomy (FP24) in patients with liver disease who are actively bleeding or who require prophylaxis for surgical bleeding
- Conditions
- Coagulopathy
- Being tested
- Resusix, FP24 (Frozen Plasma)
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResusixBiological
spray-dried solvent/detergent treated plasma (blood product)
FP24 (Frozen Plasma)Biological
plasma frozen within 24 hours of phlebotomy
| Study group | Role | What they receive |
|---|---|---|
| Resusix | Experimental | The experimental drug (Resusix) will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period. Receives: Biological: Resusix |
| FP24 (Frozen Plasma) | Active comparator | The active comparator FP24 will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period. Receives: Biological: FP24 (Frozen Plasma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in INR
Measured as a ratio
Measured: 120 minutes
Total incidence of all related SAEs
Count of events
Measured: 7 days
Secondary outcomes (12)
Change in activated partial thromboplastin time (aPTT)
Measured in seconds
Measured: 72 hours
Change in platelet count
Measured in x10.e3/uL
Measured: 72 hours
Change in hemoglobin
Measured in g/L
Measured: 72 hours
Change in clotting function
Measured by thromboelastography (TEG) or rotational thromboelastometry (ROTEM)
Measured: 72 hours
Volume of plasma to correct INR
Measured in mL
Measured: 72 hours
Time to INR reduction below 1.5
Measured in minutes
Measured: 72 hours
Volume of fluid (e.g., crystalloid, colloid, blood component) administered
Measured in mL
Measured: 72 hours
Change in bleeding score in patients with active bleeding
Measured as excellent, good or poor
Measured: 120 minutes
Thrombin generation
Measured in nM
Measured: 72 hours
Serology for human immunodeficiency virus
Measured in IU/mL
Measured: 95 days
Serology for hepatitis
Measured in IU/mL
Measured: 95 days
Change in Sequential Organ Failure Assessment Score (SOFA)
Measured as 0 to 4
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start14 Dec 2018
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Why it stopped: Convenience of Government Funding Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entegrion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Galiger, Study director, Entegrion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700723
- Sponsor's protocol ID
- RSX-201
- Status last verified
- Jan 2021
- First submitted
- 18 Sep 2018
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
- ClinicalTrials.gov ID
- NCT03700723
- Acronym / sponsor ID
- RSX-201
- Conditions
- Coagulopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Convenience of Government Funding Sponsor
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Entegrion, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2a study to assess the safety and efficacy of IV infused spray-dried solvent/detergent -treated plasma (Resusix) when compared with an equal volume of plasma frozen within 24 hours after phlebotomy (FP24) in patients with liver disease who are actively bleeding or who require prophylaxis for surgical bleeding
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized in a 1:1 ratio to receive Resusix or FP24
| Arm | Type | Receives |
|---|---|---|
| Resusix | Experimental | Biological: ResusixThe experimental drug (Resusix) will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period. |
| FP24 (Frozen Plasma) | Active comparator | Biological: FP24 (Frozen Plasma)The active comparator FP24 will be administered intravenously to subjects enrolled in this arm of the study. Subjects may receive doses of 1-4 units during the blinded intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- SBP 90-150 mm Hg
- acquired coagulopathy due to hepatic disease
- INR >1.4
- Order for 1-4 units of plasma for active bleeding or prophylaxis for bleeding prior to surgery or invasive procedure
- Written informed consent
Key exclusion criteria (13 listed)
- Pregnant women
- Incarcerated patients
- Life expectancy less than 72 hours
- Severe bleeding at time of enrollment
- HIV, sepsis, intracranial bleeding, congenital disorder, anti-phospholipid antibody syndrome or known lupus anticoagulant antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resusixspray-dried solvent/detergent treated plasma (blood product) | Biological | Resusix |
| FP24 (Frozen Plasma)plasma frozen within 24 hours of phlebotomy | Biological | FP24 (Frozen Plasma) |
Primary outcome
Change in INR
Time frame: 120 minutes
Measured as a ratio
Total incidence of all related SAEs
Time frame: 7 days
Count of events
12 secondary outcomes
Change in activated partial thromboplastin time (aPTT)
Time frame: 72 hours
Change in platelet count
Time frame: 72 hours
Change in hemoglobin
Time frame: 72 hours
Change in clotting function
Time frame: 72 hours
Volume of plasma to correct INR
Time frame: 72 hours
Time to INR reduction below 1.5
Time frame: 72 hours
Volume of fluid (e.g., crystalloid, colloid, blood component) administered
Time frame: 72 hours
Change in bleeding score in patients with active bleeding
Time frame: 120 minutes
Thrombin generation
Time frame: 72 hours
Serology for human immunodeficiency virus
Time frame: 95 days
Serology for hepatitis
Time frame: 95 days
Change in Sequential Organ Failure Assessment Score (SOFA)
Time frame: 96 hours
Results and safety
The study was stopped early (reason given: Convenience of Government Funding Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
Related trials for Coagulopathy
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Galiger study director
Entegrion, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resusix and FP24 (Frozen Plasma) in people with Coagulopathy, run by Entegrion, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Convenience of Government Funding Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in INR (time frame: 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.