Anticoagulant TherapyPhase 2NCT01541098
A Clinical Study of Lyophilized Plasma in Patients on Warfarin
A Phase 2 study testing Lyophilized Plasma and Licensed Plasma in people with Anticoagulant Therapy, run by HemCon Medical Technologies, Inc.
Trial summary
This is a multi center, phase 2 randomized controlled study to determine the effect of lyophilized plasma in patients on warfarin therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulant Therapy
- What is being tested?
- Lyophilized Plasma and Licensed Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- 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
- Patients receiving oral anticoagulation with warfarin derived agents.
- Patients who have need for urgent surgery, an invasive procedure or identification of a patient with active bleeding where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of warfarin anticoagulant effects.
- Patients with an elevated international normalized ratio.
Who cannot join
- Patients who are clinically unstable.
- Patients who have congenital or acquired coagulopathies (other than warfarin therapy).
- Patients who have received medications that could interfere with the results of laboratory testing.
- 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.
- Active illicit drug use.
About this study
Official title: A Phase II Clinical Study of Lyophilized Plasma in Patients on Warfarin
This is a multi center, phase 2 randomized controlled study to determine the effect of lyophilized plasma in patients on warfarin therapy.
- Conditions
- Anticoagulant Therapy
- Being tested
- Lyophilized Plasma, Licensed Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized PlasmaBiological
Licensed plasma that has been lyophilized.
Licensed PlasmaBiological
Plasma that has been authorized for transfusion.
| Study group | Role | What they receive |
|---|---|---|
| Licensed Plasma | Active comparator | Not described Receives: Biological: Licensed Plasma |
| Lyophilized Plasma | Experimental | Not described Receives: Biological: Lyophilized Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess and Compare Adverse Events
The primary safety objective is to assess the adverse events after infusion of lyophilized plasma compared to control.
Measured: Duration of Study (Less than or equal to 72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulant TherapyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemCon Medical Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541098
- Sponsor's protocol ID
- 2011-I-LyP-1
- Status last verified
- Mar 2015
- First submitted
- 16 Feb 2012
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Lyophilized Plasma in Patients on Warfarin
- ClinicalTrials.gov ID
- NCT01541098
- Acronym / sponsor ID
- 2011-I-LyP-1
- Conditions
- Anticoagulant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HemCon Medical Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 29 Feb 2012 (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.
This is a multi center, phase 2 randomized controlled study to determine the effect of lyophilized plasma in patients on warfarin therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Licensed Plasma | Active comparator | Biological: Licensed Plasma |
| Lyophilized Plasma | Experimental | Biological: Lyophilized Plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving oral anticoagulation with warfarin derived agents.
- Patients who have need for urgent surgery, an invasive procedure or identification of a patient with active bleeding where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of warfarin anticoagulant effects.
- Patients with an elevated international normalized ratio.
Key exclusion criteria (7 listed)
- Patients who are clinically unstable.
- Patients who have congenital or acquired coagulopathies (other than warfarin therapy).
- Patients who have received medications that could interfere with the results of laboratory testing.
- Pregnant or nursing women.
- Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
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 |
|---|---|---|
| Lyophilized PlasmaLicensed plasma that has been lyophilized. | Biological | Lyophilized Plasma |
| Licensed PlasmaPlasma that has been authorized for transfusion. | Biological | Licensed Plasma |
Primary outcome
Assess and Compare Adverse Events
Time frame: Duration of Study (Less than or equal to 72 hours)
The primary safety objective is to assess the adverse events after infusion of lyophilized plasma compared to control.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lyophilized Plasma and Licensed Plasma in people with Anticoagulant Therapy, run by HemCon Medical Technologies, Inc.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Assess and Compare Adverse Events (time frame: Duration of Study (Less than or equal to 72 hours)). 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 18 Mar 2015.