Burn InjuryFFPNCT05063409
Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting
A study testing Treatment in people with Burn Injury, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
The purpose of this study is to determine if burn injured patients who receive blood transfusions in the operating room have better outcomes when given transfusions at a set ratio (1:1)of PRBC to FFP. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 28 Feb 2020
- Phase
- Interventional
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient is 1 month to </= 18 yrs of age
- Admitted to Shriners Hospitals for Children Northern California
- Patient has a third degree burn >/= 20 % total body surface area (TBSA)
Who cannot join
- Infants < 5 kg
- Pregnancy
- 18 years of age
- Inability or unwillingness to receive blood products
- Pre-existing need for hemodialysis
- Brain death or imminent brain death
Show all 9Show fewer
- Non-survivable burn as determined by the attending burn surgeon
- Pre-existing hematologic disease
- Closed head injury with Glasgow Coma Score <9
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children Northern California
Sacramento, California, 95817
About this study
Official title: A Randomized Prospective Trial of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) Ratio: Comparison of a Traditional (1:4) to Liberal (1:1)FFP Transfusion Policy During Burn Excision and Grafting
The purpose of this study is to determine if burn injured patients who receive blood transfusions in the operating room have better outcomes when given transfusions at a set ratio (1:1)of PRBC to FFP.
Traditionally, patients that need blood transfusions during surgery are given mostly packed red blood cells (PRBC) and some fresh frozen plasma (FFP). This is usually about 1:4 ratio of FFP to PRBC.
Read more
In this study, we will compare this traditional approach (1:4) to a 1:1 ratio of FFP to PRBC during the operative period.
The hypothesis of the study is that the use of FFP/PRBC ratio of 1:1, compared to a ratio of 1:4 will result in a(n)
- decrease in the amount of blood transfused in the operating room
- decrease in the amount of blood transfused during hospitalization
- improvement in coagulation parameters (PT/PTT, INR, antithrombin III, Protein C and Fibrinogen in the operative period (from operation start to 12 hours post operatively) and at 24 hours postoperatively
- decrease the hospital length of stay, lung dysfunction, infections, and mortality
Read the detailed description
The hypothesis of the study is that the use of a fresh frozen plasma/packed red blood cells (FFP/PRBC) ratio of 1:1, compared to a ratio of 1:4 during operative excision of >20% TBSA will: result in a decrease in the amount of blood transfused in the operating room, a decrease in the amount of blood transfused during hospitalization, an improvement in coagulation parameters (PT/PTT, INR) in the operative period (from operation start to 12 hours postoperatively) and at 24 hours postoperatively, and a decrease in hospital length of stay, lung dysfunction, number of infections, and mortality.
The primary objective of the study is to determine if aggressive correction of intraoperative coagulopathy during burn excision and grafting results in improved outcomes.
- Conditions
- Burn Injury
- Being tested
- Treatment
- Keywords
- FFP, PRBC, Burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
Blood product transfusion at a ratio of 1:1 FFP to PRBC or 1:4 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively)
| Study group | Role | What they receive |
|---|---|---|
| 1:1 Ratio of FFP to PRBC | Active comparator | Randomized treatment to receive blood products at a ratio of 1:1 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively) Receives: Other: Treatment |
| 1:4 Ratio FFP to PRBC | Active comparator | Randomized treatment to receive blood products at a ratio of 1:4 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively) Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the amount of blood transfused in the operating room and during hospitalization
All transfusions during the operative period and entire hospitalization will be documented
Measured: Baseline to 12 months- From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
Secondary outcomes (6)
change in rate of survival
survival outcome as captured at discharge
Measured: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in coagulopathy in the operative period as defined by change in PT/PTT measurement
PT/PTT obtained pre and post operatively per protocol
Measured: from operation start to 12 hours post operatively
change in hospital length of stay
Number of days in hospital from admit to discharge
Measured: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in number of infectious episodes
number of new onset infections captured as defined by the Burn Sepsis Consensus Conference
Measured: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in organ dysfunction
Change in organ dysfunction as evidenced by change in MODS
Measured: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in pulmonary dysfunction
pulmonary dysfunction measured by P:F ratio and number of days on mechanical ventilation
Measured: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study startSep 2010
- Primary completion31 Dec 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tina L Palmieri, Shriners Hospitals for Children
- Investigators
- Tina Palmieri, MD, Principal investigator, SHCNC and UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063409
- Sponsor's protocol ID
- SHC 70014
- Other IDs
- 216586
- Acronym
- FFP
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2012
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Palmieri TL, Sen S, Falwell K, Greenhalgh DG. Blood product transfusion: does location make a difference? J Burn Care Res. 2011 Jan-Feb;32(1):61-5. doi: 10.1097/BCR.0b013e318204b3ea.
PubMed 21107270
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Trial of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) Ratio: Comparison of a Traditional (1:4) to Liberal (1:1)FFP Transfusion Policy During Burn Excision and Grafting
- ClinicalTrials.gov ID
- NCT05063409
- Acronym / sponsor ID
- FFP / SHC 70014
- Conditions
- Burn Injury
- Keywords
- FFP, PRBC, Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 1 Oct 2021 (actual)
- 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.
The purpose of this study is to determine if burn injured patients who receive blood transfusions in the operating room have better outcomes when given transfusions at a set ratio (1:1)of PRBC to FFP.
Traditionally, patients that need blood transfusions during surgery are given mostly packed red blood cells (PRBC) and some fresh frozen plasma (FFP). This is usually about 1:4 ratio of FFP to PRBC.
In this study, we will compare this traditional approach (1:4) to a 1:1 ratio of FFP to PRBC during the operative period.
The hypothesis of the study is that the use of FFP/PRBC ratio of 1:1, compared to a ratio of 1:4 will result in a(n)
- decrease in the amount of blood transfused in the operating room
- decrease in the amount of blood transfused during hospitalization
- improvement in coagulation parameters (PT/PTT, INR, antithrombin III, Protein C and Fibrinogen in the operative period (from operation start to 12 hours post operatively) and at 24 hours postoperatively
- decrease the hospital length of stay, lung dysfunction, infections, and mortality
Detailed description
The hypothesis of the study is that the use of a fresh frozen plasma/packed red blood cells (FFP/PRBC) ratio of 1:1, compared to a ratio of 1:4 during operative excision of >20% TBSA will: result in a decrease in the amount of blood transfused in the operating room, a decrease in the amount of blood transfused during hospitalization, an improvement in coagulation parameters (PT/PTT, INR) in the operative period (from operation start to 12 hours postoperatively) and at 24 hours postoperatively, and a decrease in hospital length of stay, lung dysfunction, number of infections, and mortality.
The primary objective of the study is to determine if aggressive correction of intraoperative coagulopathy during burn excision and grafting results in improved outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1:1 Ratio of FFP to PRBC | Active comparator | Other: TreatmentRandomized treatment to receive blood products at a ratio of 1:1 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively) |
| 1:4 Ratio FFP to PRBC | Active comparator | Other: TreatmentRandomized treatment to receive blood products at a ratio of 1:4 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively) |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient is 1 month to </= 18 yrs of age
- Admitted to Shriners Hospitals for Children Northern California
- Patient has a third degree burn >/= 20 % total body surface area (TBSA)
Key exclusion criteria (9 listed)
- Infants < 5 kg
- Pregnancy
- Inability or unwillingness to receive blood products
- Pre-existing need for hemodialysis
- Brain death or imminent brain death
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 |
|---|---|---|
| TreatmentBlood product transfusion at a ratio of 1:1 FFP to PRBC or 1:4 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively) | Other | 1:1 Ratio of FFP to PRBC, 1:4 Ratio FFP to PRBC |
Primary outcome
change in the amount of blood transfused in the operating room and during hospitalization
Time frame: Baseline to 12 months- From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
All transfusions during the operative period and entire hospitalization will be documented
6 secondary outcomes
change in rate of survival
Time frame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in coagulopathy in the operative period as defined by change in PT/PTT measurement
Time frame: from operation start to 12 hours post operatively
change in hospital length of stay
Time frame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in number of infectious episodes
Time frame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in organ dysfunction
Time frame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
change in pulmonary dysfunction
Time frame: From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months
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 1 Oct 2021.
- Background: PubMed 21107270Palmieri TL, Sen S, Falwell K, Greenhalgh DG. Blood product transfusion: does location make a difference? J Burn Care Res. 2011 Jan-Feb;32(1):61-5. doi: 10.1097/BCR.0b013e318204b3ea.
- Individual participant dataSharing planned: No
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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.
Tina Palmieri, MD principal investigator
SHCNC and UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Burn Injury, run by Shriners Hospitals for Children 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 3 inclusion and 9 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 1 Oct 2021. 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?
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?
change in the amount of blood transfused in the operating room and during hospitalization (time frame: Baseline to 12 months- From date of hospital admit to date of hospital discharge, assessed over duration of hospitalization up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063409, which also lists 1 linked publication.
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 1 Oct 2021.