CoagulationPhase 1/2NCT00302965
Effectiveness of Plasma Transfusions in Critical Care Patients
A Phase 1/2 study testing Frozen Plasma in people with Coagulation, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Measuring the effectiveness of plasma transfusions in critical care Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coagulation
- What is being tested?
- Frozen Plasma
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Dec 2006
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ICU Admission
- INR > 1.2
- Require FFP for active bleeding and/or prior to an invasive procedure
- Are able to provide consent or proxy consent
Who cannot join
- Congenital or acquired coagulation factor deficiency
- Platelet count < 50 x 109 /L and have NOT received subsequent platelet transfusion
- Consumptive coagulopathy (bleeding ≥ 3 sites and ↓ plts, ↓ fib, ↑ d dimer)
- Uncontrolled bleeding (6 or more units of blood in the last 6 hours)
- Receiving therapeutic doses of heparin/heparinoid (must be off for at least 6 hours)
- Have received clotting factor concentrates in the previous 24 hours
Show all 10Show fewer
- Are expected to require surgery in the next 48 hours
- Survival expected to be less than 48 hours
- Currently enrolled in another study with a similar outcome
- Previous enrollment in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Fresh Frozen Plasma in Critical Care (EPICC) Trial
Measuring the effectiveness of plasma transfusions in critical care
Read the detailed description
Measuring the effectiveness of plasma transfusions in critical care
- Conditions
- Coagulation
- Being tested
- Frozen Plasma
- Keywords
- Plasma, Trauma, Critical Care
- Medical subject headings
- Thrombosis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frozen PlasmaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients with a correction of the INR (Determined by the treating physician)
Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels
bleeding and complications from FFP (fluid overload, transfusion reactions).
Secondary outcomes (2)
Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels
bleeding and complications from FFP (fluid overload, transfusion reactions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startApr 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulationStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Alan Tinmouth, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302965
- Sponsor's protocol ID
- 2004341-01
- Status last verified
- Oct 2008
- First submitted
- 13 Sep 2005
- Last updated
- 21 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Fresh Frozen Plasma in Critical Care (EPICC) Trial
- ClinicalTrials.gov ID
- NCT00302965
- Acronym / sponsor ID
- 2004341-01
- Conditions
- Coagulation
- Keywords
- Plasma, Trauma, Critical Care
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Mar 2006 (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.
Measuring the effectiveness of plasma transfusions in critical care
Detailed description
Measuring the effectiveness of plasma transfusions in critical care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ICU Admission
- INR > 1.2
- Require FFP for active bleeding and/or prior to an invasive procedure
- Are able to provide consent or proxy consent
Key exclusion criteria (10 listed)
- Congenital or acquired coagulation factor deficiency
- Platelet count < 50 x 109 /L and have NOT received subsequent platelet transfusion
- Consumptive coagulopathy (bleeding ≥ 3 sites and ↓ plts, ↓ fib, ↑ d dimer)
- Uncontrolled bleeding (6 or more units of blood in the last 6 hours)
- Receiving therapeutic doses of heparin/heparinoid (must be off for at least 6 hours)
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 |
|---|---|---|
| Frozen Plasma | Drug | – |
Primary outcome
the proportion of patients with a correction of the INR (Determined by the treating physician)
Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels
bleeding and complications from FFP (fluid overload, transfusion reactions).
2 secondary outcomes
Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels
bleeding and complications from FFP (fluid overload, transfusion reactions).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
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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.
Alan Tinmouth, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Frozen Plasma in people with Coagulation, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 10 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 21 Oct 2008. 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 Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the proportion of patients with a correction of the INR (Determined by the treating physician). The study lists 3 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 21 Oct 2008.