Blood Coagulation DisordersPhase 3NCT02637427
Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures
A Phase 3 study testing Fresh frozen plasma transfusion in people with Blood Coagulation Disorders and Hemorrhage, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Blood Coagulation Disorders, Hemorrhage
- What is being tested?
- Fresh frozen plasma transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2016to Nov 2020
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- INR level between 1.50 and 2.50 inclusive
- undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology
Who cannot join
- undergoing a surgical procedure in the operating room;
- active bleeding;
- undergoing a procedure involving or proximal to the central nervous system or spinal cord;
- cardiac catheterization,
- using 4 factor plasma concentrates
- using systemic heparin/heparinoid therapy, direct factor X inhibitors and other anticoagulants for which plasma will not correct prolonged INR;
Show all 11Show fewer
- platelet count less than 50,000/ul,
- congenital coagulation disorders;
- acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the disorder;
- women who are pregnant and;
- unwillingness to consider blood transfusion.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University, The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
About this study
The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure.
Read the detailed description
Fresh frozen plasma is used very frequently in the US. Many plasma transfusions are given prior to a procedure in order to correct perceived bleeding risk, yet there is little evidence to support that use of plasma reduces bleeding. There has never been an adequately powered trial to establish the efficacy of plasma and document the risks. This pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of prophylactic plasma transfusion in patients with moderately elevated INRs prior to undergoing an invasive procedure outside of the operating room.
Study subjects will be randomly allocated to either receive either plasma transfusion prior to the procedure, or to no treatment. Study outcomes will be compared between the two study arms. Recruitment rates, protocol adherence, and rates of study outcomes will be assessed to determine the feasibility of the large scale trial.
- Conditions
- Blood Coagulation Disorders, Hemorrhage
- Being tested
- Fresh frozen plasma transfusion
- Keywords
- Fresh frozen plasma, Bleeding
- Medical subject headings
- Blood Coagulation Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh frozen plasma transfusionBiological
Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
| Study group | Role | What they receive |
|---|---|---|
| Fresh frozen plasma transfusion | Experimental | Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units) Receives: Biological: Fresh frozen plasma transfusion |
| No transfusion | No intervention | No transfusions prior to the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Level
Change from pre-procedure hemoglobin to lowest within 2 days after procedure
Measured: within 2 days post procedure
Secondary outcomes (10)
Number of Red Blood Cell Transfusions
Differences in number of units of red blood cell transfusions between the two study arms
Measured: within 2 days post procedure
Number of Participants With Transfusion Associated Cardiac Overload (TACO)
Difference in rates between the two study arms
Measured: within 2 days post procedure
Number of Participants With Transfusion Related Acute Lung Injury (TRALI).
Difference in rates between the two study arms
Measured: with 2 days post procedure
Number of Participants With Major Bleed
2g/dL or greater fall in hemoglobin level
Measured: with 2 days post procedure
Change in International Normalized Ratio (INR) Level Post Procedure
Change from pre-procedure INR level
Measured: day of procedure
Change in INR Level Day 1
Change from pre-procedure INR level
Measured: day 1 post procedure
Change in INR Level Day 2
Change from pre-procedure INR level
Measured: day 2 post procedure
Mortality (Number of Participants)
Death
Measured: in-hospital up to 7 days
Number of Participants With Infection
Pneumonia or blood stream infection
Measured: within 2 days post procedure
Number of Participants With ICU Admission
new admission to the intensive care unit
Measured: within 2 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start26 Feb 2016
- Primary completion28 Jun 2019
- Study completionNov 2020
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 Blood Coagulation DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Johns Hopkins University, University of Washington, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
- Investigators
- Jeffrey L Carson, MD, Study chair, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637427
- Sponsor's protocol ID
- Pro20150001801
- Other IDs
- 1R34HL125804-01A1
- Status last verified
- Aug 2021
- First submitted
- 16 Dec 2015
- Last updated
- 18 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures
- ClinicalTrials.gov ID
- NCT02637427
- Acronym / sponsor ID
- Pro20150001801
- Conditions
- Blood Coagulation Disorders, Hemorrhage
- Keywords
- Fresh frozen plasma, Bleeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Johns Hopkins University, University of Washington, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Posted 17 Aug 2021
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 evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure.
Detailed description
Fresh frozen plasma is used very frequently in the US. Many plasma transfusions are given prior to a procedure in order to correct perceived bleeding risk, yet there is little evidence to support that use of plasma reduces bleeding. There has never been an adequately powered trial to establish the efficacy of plasma and document the risks. This pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of prophylactic plasma transfusion in patients with moderately elevated INRs prior to undergoing an invasive procedure outside of the operating room.
Study subjects will be randomly allocated to either receive either plasma transfusion prior to the procedure, or to no treatment. Study outcomes will be compared between the two study arms. Recruitment rates, protocol adherence, and rates of study outcomes will be assessed to determine the feasibility of the large scale trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh frozen plasma transfusion | Experimental | Biological: Fresh frozen plasma transfusionPre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units) |
| No transfusion | No intervention | –No transfusions prior to the procedure |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- INR level between 1.50 and 2.50 inclusive
- undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology
Key exclusion criteria (11 listed)
- undergoing a surgical procedure in the operating room;
- active bleeding;
- undergoing a procedure involving or proximal to the central nervous system or spinal cord;
- cardiac catheterization,
- using 4 factor plasma concentrates
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 |
|---|---|---|
| Fresh frozen plasma transfusionPre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units) | Biological | Fresh frozen plasma transfusion |
Primary outcome
Change in Hemoglobin Level
Time frame: within 2 days post procedure
Change from pre-procedure hemoglobin to lowest within 2 days after procedure
10 secondary outcomes
Number of Red Blood Cell Transfusions
Time frame: within 2 days post procedure
Number of Participants With Transfusion Associated Cardiac Overload (TACO)
Time frame: within 2 days post procedure
Number of Participants With Transfusion Related Acute Lung Injury (TRALI).
Time frame: with 2 days post procedure
Number of Participants With Major Bleed
Time frame: with 2 days post procedure
Change in International Normalized Ratio (INR) Level Post Procedure
Time frame: day of procedure
Change in INR Level Day 1
Time frame: day 1 post procedure
Change in INR Level Day 2
Time frame: day 2 post procedure
Mortality (Number of Participants)
Time frame: in-hospital up to 7 days
Number of Participants With Infection
Time frame: within 2 days post procedure
Number of Participants With ICU Admission
Time frame: within 2 days post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- 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.
Jeffrey L Carson, MD study chair
Rutgers Robert Wood Johnson Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fresh frozen plasma transfusion in people with Blood Coagulation Disorders and Hemorrhage, run by Rutgers, The State University of New Jersey at 2 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 2 inclusion and 11 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 17 Aug 2021). 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?
Change in Hemoglobin Level (time frame: within 2 days post procedure). 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 Aug 2021.