CoagulopathyNCT02037373
Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation
An observational study of Coagulopathy and Endstage Liver Disease, run by Octapharma at 4 sites in United States.
Trial summary
Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulopathy, Endstage Liver Disease
- What is being tested?
- Octaplas™ and Plasma
- Type of treatment
- Injection or infusion
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2015to Feb 2018
- Phase
- Observational
- 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
Study population: Study population will include patients undergoing orthotopic liver transplantation
Who may be able to join
- Male or female age ≥18 years
- Patient is scheduled to undego orthotopic liver transplantation (OLT)
- Patient has a natural MAYO End-Stage Liver Disease (MELD) score of 15-40
- Patient is willing to give voluntary written informed consent before any study- related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care
Who cannot join
- Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product
- Patient is known to be IgA deficient with documented antibodies against IgA
- Patient is a planned recipient for a living donor OLT
- Patient has a severe deficiency of Protein S
- Patient is currently participating in an interventional clinical study or has participated in one within 30 days of the date of their OLT
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Octapharma Research Site
Loma Linda, California, 92354
Octapharma Research Site
Nashville, Tennessee, 37232
Octapharma Research Site
Philadelphia, Pennsylvania, 19141
Octapharma Research Site
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Post-Marketing Requirement Study to Evaluate the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation With Special Emphasis on Hyperfibrinolysis.
Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma products).
- Conditions
- Coagulopathy, Endstage Liver Disease
- Being tested
- Octaplas™, Plasma
- Keywords
- intra and post-op coagulopathy in patients undergoing OLT
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octaplas™Biological
Octaplas™ infusion solution for IV administration as prescribed by the treating physician.
PlasmaBiological
Also called FFP and other approved plasma products
Plasma as prescribed by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Octaplas™ | Patients treated with Octaplas™ infusion solution for IV administration as prescribed by their treating physician. Receives: Biological: Octaplas™ | |
| Plasma | Patients treated with regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products). Receives: Biological: Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of hyperfibinolysis in patients undergoing OLT receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products).
The incidence of 'clinically relevant hyperfibrinolytic events' in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma. For this trial a 'clinically relevant hyperfibrinolytic event' is defined as a decrease of at least 7.5% in the maximum amplitude (MA) as measured by the thromboelastography (TEG) or rotational thromboelastography (ROTEM) within 30 minutes after MA is achieved and the event is associated with bleeding requiring intervention.
Measured: 3 days (perioperative period plus post-operative follow-up)
Secondary outcomes (1)
The safety of octaplas™ in comparison to plasma will be assessed by monitoring the occurrence of adverse drug reactions (i.e., transfusion reactions).
The incidence of all adverse drug reactions (i.e., transfusion reactions) during the study period among patients receiving octaplas™ in comparison to standard plasma products.
Measured: 3 days (perioperative period plus post-operative follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startAug 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: FDA released requirement to complete study
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.
- More trials run by OctapharmaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Frenzel, Study director, International Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037373
- Sponsor's protocol ID
- LAS-215
- Status last verified
- Mar 2018
- First submitted
- 14 Jan 2014
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Requirement Study to Evaluate the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation With Special Emphasis on Hyperfibrinolysis.
- ClinicalTrials.gov ID
- NCT02037373
- Acronym / sponsor ID
- LAS-215
- Conditions
- Coagulopathy, Endstage Liver Disease
- Keywords
- intra and post-op coagulopathy in patients undergoing OLT
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: FDA released requirement to complete study
- Enrolment
- 43 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 15 Jan 2014 (estimated)
- 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.
Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma products).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octaplas™ | – | Biological: Octaplas™Patients treated with Octaplas™ infusion solution for IV administration as prescribed by their treating physician. |
| Plasma | – | Biological: PlasmaPatients treated with regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include patients undergoing orthotopic liver transplantation
Key inclusion criteria (4 listed)
- Male or female age ≥18 years
- Patient is scheduled to undego orthotopic liver transplantation (OLT)
- Patient has a natural MAYO End-Stage Liver Disease (MELD) score of 15-40
- Patient is willing to give voluntary written informed consent before any study- related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care
Key exclusion criteria (5 listed)
- Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product
- Patient is known to be IgA deficient with documented antibodies against IgA
- Patient is a planned recipient for a living donor OLT
- Patient has a severe deficiency of Protein S
- Patient is currently participating in an interventional clinical study or has participated in one within 30 days of the date of their OLT
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 |
|---|---|---|
| Octaplas™Octaplas™ infusion solution for IV administration as prescribed by the treating physician. | Biological | Octaplas™ |
| PlasmaAlso: FFP and other approved plasma productsPlasma as prescribed by the treating physician. | Biological | Plasma |
Primary outcome
To assess the incidence of hyperfibinolysis in patients undergoing OLT receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products).
Time frame: 3 days (perioperative period plus post-operative follow-up)
The incidence of 'clinically relevant hyperfibrinolytic events' in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma. For this trial a 'clinically relevant hyperfibrinolytic event' is defined as a decrease of at least 7.5% in the maximum amplitude (MA) as measured by the thromboelastography (TEG) or rotational thromboelastography (ROTEM) within 30 minutes after MA is achieved and the event is associated with bleeding requiring intervention.
1 secondary outcome
The safety of octaplas™ in comparison to plasma will be assessed by monitoring the occurrence of adverse drug reactions (i.e., transfusion reactions).
Time frame: 3 days (perioperative period plus post-operative follow-up)
Results and safety
The study was stopped early (reason given: FDA released requirement to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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.
Wolfgang Frenzel study director
International Medical Monitor
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulopathy and Endstage Liver Disease, run by Octapharma at 4 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 4 inclusion and 5 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study was stopped early (reason given: FDA released requirement to complete study). 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?
To assess the incidence of hyperfibinolysis in patients undergoing OLT receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products). (time frame: 3 days (perioperative period plus post-operative follow-up)). 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 Mar 2018.