Extracorporeal Membrane OxygenationNCT01903863
The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity
A study testing Fresh frozen plasma in people with Extracorporeal Membrane Oxygenation, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation
- What is being tested?
- Fresh frozen plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Apr 2016
- Phase
- Interventional
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients < 18 years receiving ECMO
Who cannot join
- Planned withdrawal of life sustaining therapy in the next 48 hours
- Previous enrollment in the study
- Patients who cannot be consented within 48 hours
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center PICU and PCICU
Durham, North Carolina, 27710
About this study
Official title: Prospective, Randomized Pilot Study of Prophylactic Fresh Frozen Plasma Administration During Neonatal-Pediatric Extracorporeal Membrane Oxygenation.
The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump changes. In addition, this may lead to less overall transfusion with all products (red blood cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and pediatric cardiac critical care units. Subjects will be randomized to receive every other day FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours) and FFP use will be compared between the two groups There is a small risk that study subjects may receive more FFP transfusions and therefore have the increased associated risks however it is also possible that these subjects may benefit from less ECMO circuit changes and/or fewer transfusions of all blood products.
- Conditions
- Extracorporeal Membrane Oxygenation
- Being tested
- Fresh frozen plasma
- Keywords
- FFP, fresh frozen plasma, ECMO, extracorporeal membrane oxygenation, anticoagulation, transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh frozen plasmaBiological
Also called FFP, plasma
Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
| Study group | Role | What they receive |
|---|---|---|
| Scheduled fresh frozen plasma | Experimental | Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours. Receives: Biological: Fresh frozen plasma |
| Control | Active comparator | Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. Receives: Biological: Fresh frozen plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECMO Pump Longevity
The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours
Measured: ECMO course (median 198 hours)
Secondary outcomes (7)
Hemorrhagic and Thrombotic Complications
Complications associated with coagulation in both the patient and the pump will be collected.
Measured: ECMO course (median 198 hours)
Antithrombin Levels
Compared antithrombin levels in neonates in control versus treatment group
Measured: ECMO course (median 198 hours)
Plasma Free Hemoglobin
Compare plasma free hemoglobin levels between control and treatment group
Measured: ECMO course (median 198 hours)
Red Blood Cell Transfusion
Compared red blood cell transfusion during ECMO for control versus treatment group
Measured: ECMO course (median 198 hours)
Time to Therapeutic aPTT
Compared time in hours to goal aPTT for control versus treatment group
Measured: ECMO course (median 198 hours)
Platelets Transfusion Requirement
Compared platelet transfusion during ECMO for control versus treatment group
Measured: ECMO course (median 198 hours)
Fresh Frozen Plasma Transfusion Requirements
Compared fresh frozen plasma transfusion during ECMO for control versus treatment group
Measured: ECMO course (median 198 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion18 Feb 2016
- Study completionApr 2016
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 Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903863
- Sponsor's protocol ID
- Pro00040223
- Status last verified
- May 2017
- First submitted
- 17 Jul 2013
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Pilot Study of Prophylactic Fresh Frozen Plasma Administration During Neonatal-Pediatric Extracorporeal Membrane Oxygenation.
- ClinicalTrials.gov ID
- NCT01903863
- Acronym / sponsor ID
- Pro00040223
- Conditions
- Extracorporeal Membrane Oxygenation
- Keywords
- FFP, fresh frozen plasma, ECMO, extracorporeal membrane oxygenation, anticoagulation, transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 18 Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Posted 27 Jun 2017
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 assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump changes. In addition, this may lead to less overall transfusion with all products (red blood cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and pediatric cardiac critical care units. Subjects will be randomized to receive every other day FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours) and FFP use will be compared between the two groups There is a small risk that study subjects may receive more FFP transfusions and therefore have the increased associated risks however it is also possible that these subjects may benefit from less ECMO circuit changes and/or fewer transfusions of all blood products.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scheduled fresh frozen plasma | Experimental | Biological: Fresh frozen plasmaPatients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours. |
| Control | Active comparator | Biological: Fresh frozen plasmaPatients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients < 18 years receiving ECMO
Key exclusion criteria (4 listed)
- Planned withdrawal of life sustaining therapy in the next 48 hours
- Previous enrollment in the study
- Patients who cannot be consented within 48 hours
- Pregnant patients
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 plasmaAlso: FFP, plasmaFresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. | Biological | Control, Scheduled fresh frozen plasma |
Primary outcome
ECMO Pump Longevity
Time frame: ECMO course (median 198 hours)
The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours
7 secondary outcomes
Hemorrhagic and Thrombotic Complications
Time frame: ECMO course (median 198 hours)
Antithrombin Levels
Time frame: ECMO course (median 198 hours)
Plasma Free Hemoglobin
Time frame: ECMO course (median 198 hours)
Red Blood Cell Transfusion
Time frame: ECMO course (median 198 hours)
Time to Therapeutic aPTT
Time frame: ECMO course (median 198 hours)
Platelets Transfusion Requirement
Time frame: ECMO course (median 198 hours)
Fresh Frozen Plasma Transfusion Requirements
Time frame: ECMO course (median 198 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh frozen plasma in people with Extracorporeal Membrane Oxygenation, run by Duke University 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 1 inclusion and 4 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 27 Jun 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2017). 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?
ECMO Pump Longevity (time frame: ECMO course (median 198 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 27 Jun 2017.