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Blood Product
Fresh Frozen Plasma vs Albumin for Burns (FFP Trial)
N/A
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult thermal injury patients aged 2-18 years old with burns >20% TBSA seen at UCH Burn Center within 8 hours of burn injury
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
FFP Trial Summary
This trial will compare the use of fresh frozen plasma (FFP) to albumin in burn resuscitations, in order to determine the optimal colloid.
Who is the study for?
This trial is for children and young adults aged 2-18 with severe burns covering more than 20% of their body, seen at UCH Burn Center within 8 hours of injury. It excludes those who can't receive blood products, have severe coagulation or liver issues, are prisoners, pregnant, or have certain types of injuries or kidney disease.Check my eligibility
What is being tested?
The study compares the use of fresh frozen plasma (FFP) versus albumin in acute burn resuscitation to see which is better for managing fluid needs and correcting endothelial damage caused by burns. The goal is to improve care in prolonged field scenarios.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to plasma or albumin, fluid overload leading to swelling or heart problems, and complications related to blood transfusions such as infections.
FFP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a child (2-18 years) with burns covering more than 20% of my body, seen within 8 hours of the injury.
FFP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total volume of fluid administered in 24 hours in each group (FFP or albumin), measured as mL/kg/%TBSA burned.
FFP Trial Design
2Treatment groups
Active Control
Group I: Fresh Frozen PlasmaActive Control1 Intervention
At 6-8 hours, Initiate FFP infusion
Group II: AlbuminActive Control1 Intervention
At 7 hours, Initiate 5% Albumin infusion
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,426 Total Patients Enrolled
3 Trials studying Burns
146 Patients Enrolled for Burns
United States Department of DefenseFED
865 Previous Clinical Trials
327,599 Total Patients Enrolled
17 Trials studying Burns
1,423 Patients Enrolled for Burns
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe injuries that are life-threatening.I have moderate to severe liver cirrhosis.I have had kidney failure that needed dialysis.I have suffered a chemical injury.You have a skin injury caused by rubbing or pressure.My kidney disease is in stage IV or V.My burn treatment started more than 8 hours after the injury.I am currently receiving blood transfusions for a reason other than cancer.I am a Jehovah's Witness or cannot receive blood products.I am a child (2-18 years) with burns covering more than 20% of my body, seen within 8 hours of the injury.You have experienced an electric shock injury.
Research Study Groups:
This trial has the following groups:- Group 1: Fresh Frozen Plasma
- Group 2: Albumin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the eligibility criteria for this clinical trial inclusive of individuals aged 55 and older?
"Those wishing to be included in this study must have attained legal adulthood and not yet reached the century mark."
Answered by AI
Is this experiment still accepting participants?
"Affirmative, the information hosted on clinicaltrials.gov illustrates that this medical trial is presently accepting candidates. The research was initially made available to view on February 17th 2022 and has been amended for accuracy as recently as February 22nd 2022. This study requires 100 individuals from 1 centre."
Answered by AI
May I join the investigation of this clinical trial?
"A total of 100 individuals aged between 18 and 100 who have suffered from at least 20% TBSA burn injury, must be observed within 8 hours of the incident by the UCH Burn Center to qualify for this trial."
Answered by AI
What is the total number of people enrolled in this clinical research?
"Affirmative. According to clinicaltrials.gov, this medical experiment has been recruiting since February 17th 2022 and the most recent edit was done on February 22nd of that same year. Thus far, 1 site is enrolling 100 individuals in total."
Answered by AI
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