Reversal of Anticoagulant TreatmentPhase 3NCT00618098
Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
A Phase 3 study testing Octaplex (human prothrombin complex concentrate) and Fresh frozen plasma in people with Reversal of Anticoagulant Treatment, run by Octapharma at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reversal of Anticoagulant Treatment
- What is being tested?
- Octaplex (human prothrombin complex concentrate) and Fresh frozen plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female patients at least 18 years of age.
- Patients receiving oral anticoagulation with coumadin or warfarin derived agents.
- Patients who have need for urgent surgery or an invasive procedure up to 8 hours after admission or identification of a patient currently hospitalized, where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of coumadin or warfarin anticoagulant effects.
- Patients with an international normalized ratio (INR) of 2.0 or above.
- Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf.
- Patients able and willing to comply with the procedures laid out in the study protocol. In the case of unconscious and/or incapacitated patients, the willingness of the patient's legal representative for the patient to undergo the procedures laid out in the study protocol.
Who cannot join
- Patients with a life expectancy of less than 48 hours (eg, patients with a Glasgow Coma Scale (GCS) equal to 3 or a head abbreviated injury score (AIS) of 6, patients requiring continuous inotropic or pressor support, patients status post-cardiac arrest).
- Patients with a history within the last 6 months of disseminated intravascular coagulation (DIC), or hyperfibrinolysis.
- Patients with a known congenital coagulation disorder.
- Patients with known antiphospholipid antibody syndrome or have known lupus anticoagulant antibodies.
- Patients with present or past specific factor inhibitor activity.
- Patients with thrombocytopenia of < 80,000 or a history of heparin induced thrombocytopenia (HIT).
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- Patients having received heparin of any type or any non-coumadin or warfarin anticoagulant immediately prior and/or intended to be given within the first 1 hour post-infusion.
- Patients who have received vitamin K more than 3 hours prior to the infusion of study drug.
- Patients with a history of hypersensitivity to plasma-derived products.
- Pregnant or nursing women.
- Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
- Patients previously enrolled in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Octapharma for Facility details
Philadelphia, Pennsylvania, 19141
About this study
Official title: A Randomized, Open-label, Efficacy and Safety Study of Octaplex and Fresh Frozen Plasma (FFP) in Patients Under Vitamin K Antagonist Therapy With the Need for Urgent Surgery or Invasive Procedures
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
Read the detailed description
The primary objective of the study is to demonstrate that the efficacy of Octaplex as a reversal agent in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures was not clinically inferior to that of FFP.
The secondary objective of the study is to investigate the safety and tolerability of Octaplex compared to FFP in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures.
- Conditions
- Reversal of Anticoagulant Treatment
- Being tested
- Octaplex (human prothrombin complex concentrate), Fresh frozen plasma
- Keywords
- anticoagulant reversal, urgent surgery, invasive procedures, vitamin K, prothrombin complex concentrate
- Medical subject headings
- Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octaplex (human prothrombin complex concentrate)Biological
INR is determined 15 minutes after the end of each infusion. Each dose (mL/kg body weight) was calculated as = ln(INR/1.4)/0.52. The maximum dose for initial treatment was not to exceed 5500 IU. If the INR is ≥ 1.5 after the initial infusion, additional infusions will be repeated until the INR was < 1.5. Octaplex (500 units, IU) is supplied in vials and was reconstituted with 20 mL of Water for Injection (Ph.Eur.).
Fresh frozen plasmaBiological
Also called FFP
INR is determined 15 minutes after the end of each infusion. The initial dose is 10 mL/kg for a participant with an initial INR of < 3 and 15 mL/kg for a participant with an initial INR of ≥ 3. If the INR is ≥ 1.5 after the initial infusion, additional infusions of 5 mL/kg will be repeated until the INR was < 1.5. Fresh frozen plasma is supplied by the blood bank at each study site and will be prepared and handled according to the site's standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Octaplex (human prothrombin complex concentrate) | Experimental | Participants to receive1 or more Octaplex infusions intravenously until their International Normalized Ratio (INR) was < 1.5. Receives: Biological: Octaplex (human prothrombin complex concentrate) |
| Fresh frozen plasma | Active comparator | Participants to receive1 or more fresh frozen plasma infusions intravenously until their International Normalized Ratio (INR) was < 1.5. Receives: Biological: Fresh frozen plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
INR Response
Number of patients who had an INR response, defined as the correction of patient's INR to <1.5, 15 minutes after the end of first infusion with study medication
Measured: 15 minutes after the end of first infusion of OCTAPLEX or FFP
RBC Transfusion Units
Total number of intra-operative units of red blood cell (RBC) given to patients
Measured: Intra-operative; throughout the duration of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Reversal of Anticoagulant TreatmentStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Frenzel, MD, Study director, International Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618098
- Sponsor's protocol ID
- LEX-205
- Status last verified
- Jan 2023
- First submitted
- 5 Feb 2008
- Last updated
- 31 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Efficacy and Safety Study of Octaplex and Fresh Frozen Plasma (FFP) in Patients Under Vitamin K Antagonist Therapy With the Need for Urgent Surgery or Invasive Procedures
- ClinicalTrials.gov ID
- NCT00618098
- Acronym / sponsor ID
- LEX-205
- Conditions
- Reversal of Anticoagulant Treatment
- Keywords
- anticoagulant reversal, urgent surgery, invasive procedures, vitamin K, prothrombin complex concentrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Posted 31 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
Detailed description
The primary objective of the study is to demonstrate that the efficacy of Octaplex as a reversal agent in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures was not clinically inferior to that of FFP.
The secondary objective of the study is to investigate the safety and tolerability of Octaplex compared to FFP in patients under vitamin K antagonist therapy with the need for urgent surgery or invasive procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octaplex (human prothrombin complex concentrate) | Experimental | Biological: Octaplex (human prothrombin complex concentrate)Participants to receive1 or more Octaplex infusions intravenously until their International Normalized Ratio (INR) was < 1.5. |
| Fresh frozen plasma | Active comparator | Biological: Fresh frozen plasmaParticipants to receive1 or more fresh frozen plasma infusions intravenously until their International Normalized Ratio (INR) was < 1.5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients at least 18 years of age.
- Patients receiving oral anticoagulation with coumadin or warfarin derived agents.
- Patients who have need for urgent surgery or an invasive procedure up to 8 hours after admission or identification of a patient currently hospitalized, where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of coumadin or warfarin anticoagulant effects.
- Patients with an international normalized ratio (INR) of 2.0 or above.
- Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf.
Key exclusion criteria (12 listed)
- Patients with a life expectancy of less than 48 hours (eg, patients with a Glasgow Coma Scale (GCS) equal to 3 or a head abbreviated injury score (AIS) of 6, patients requiring continuous inotropic or pressor support, patients status post-cardiac arrest).
- Patients with a history within the last 6 months of disseminated intravascular coagulation (DIC), or hyperfibrinolysis.
- Patients with a known congenital coagulation disorder.
- Patients with known antiphospholipid antibody syndrome or have known lupus anticoagulant antibodies.
- Patients with present or past specific factor inhibitor activity.
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 |
|---|---|---|
| Octaplex (human prothrombin complex concentrate)INR is determined 15 minutes after the end of each infusion. Each dose (mL/kg body weight) was calculated as = ln(INR/1.4)/0.52. The maximum dose for initial treatment was not to exceed 5500 IU. If the INR is ≥ 1.5 after the initial infusion, additional infusions will be repeated until the INR was < 1.5. Octaplex (500 units, IU) is supplied in vials and was reconstituted with 20 mL of Water for Injection (Ph.Eur.). | Biological | Octaplex (human prothrombin complex concentrate) |
| Fresh frozen plasmaAlso: FFPINR is determined 15 minutes after the end of each infusion. The initial dose is 10 mL/kg for a participant with an initial INR of < 3 and 15 mL/kg for a participant with an initial INR of ≥ 3. If the INR is ≥ 1.5 after the initial infusion, additional infusions of 5 mL/kg will be repeated until the INR was < 1.5. Fresh frozen plasma is supplied by the blood bank at each study site and will be prepared and handled according to the site's standard practice. | Biological | Fresh frozen plasma |
Primary outcome
INR Response
Time frame: 15 minutes after the end of first infusion of OCTAPLEX or FFP
Number of patients who had an INR response, defined as the correction of patient's INR to <1.5, 15 minutes after the end of first infusion with study medication
RBC Transfusion Units
Time frame: Intra-operative; throughout the duration of operation
Total number of intra-operative units of red blood cell (RBC) given to patients
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MD study director
International Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octaplex (human prothrombin complex concentrate) and Fresh frozen plasma in people with Reversal of Anticoagulant Treatment, run by Octapharma at 1 site 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 12 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: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
INR Response (time frame: 15 minutes after the end of first infusion of OCTAPLEX or FFP). 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 31 Jan 2023.