Plasma Resuscitation Without Lung Injury (PROPOLIS)
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| ClinicalTrials.gov Identifier: NCT04681638 |
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Recruitment Status :
Not yet recruiting
First Posted : December 23, 2020
Last Update Posted : August 30, 2021
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Sponsor:
Coalition for National Trauma Research
Collaborator:
Cerus Corporation
Information provided by (Responsible Party):
Coalition for National Trauma Research
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Brief Summary:
The treatment of patients with major burns requires resuscitation with massive amounts of fluid, typically a type of salt water that is given by vein. This frequently results in injury to vital organs, especially the lungs and kidneys, and even in death. In this study, the investigators propose to use plasma, a specially prepared blood product made from the liquid part of blood, that has undergone special treatment to reduce the risk of disease transmission. The aims include 1) reduce the amount of fluid given during the first 24 hours after a burn 2) reduce the incidence of lung injury and other complications related to the administration of funds and 3) determine if the blood product has any effect on inflammation. An overall decrease the amount of fluids that burn patients receive should decrease the potential for lung injury, decrease days in the hospital, and improve survival.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Burns | Drug: Pathogen-Reduced Plasma Drug: Crystalloid Solutions | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 94 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is an open-label, phase IV, multicenter, randomized controlled prospective clinical trial in patients with burns. The study model is parallel (between-patient). The intervention to be tested is Pathogen-Reduced Plasma for burn shock resuscitation vs. standard-of-care resuscitation. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Plasma Resuscitation withOut Lung Injury |
| Estimated Study Start Date : | September 2021 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | September 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Plasma
Pathogen-Reduced Plasma resuscitation
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Drug: Pathogen-Reduced Plasma
The treatment group will receive an additional infusion of Pathogen-Reduced Plasma based on the formula, hourly rate, mL/hr = (1 mL*kg*TBSA)/24 hr. This infusion will not be titrated. It will be discontinued at the end of the 24th postburn hour.
Other Name: PRP |
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Active Comparator: Crystalloid
Standardized crystalloid resuscitation
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Drug: Crystalloid Solutions
The control group will receive an additional infusion of LR based on the formula: hourly rate, mL/hr = (1mL*kg*TBSA)/24 hr. this infusion will not be titrated. It will be discontinued at the end of the 24th postburn hour.
Other Name: LR |
Primary Outcome Measures :
- The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg. [ Time Frame: 24 hours ]The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg
Secondary Outcome Measures :
- Total resuscitation volume in ml/kg [ Time Frame: 48 hours ]The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg
- Total 24 hour resuscitation volume in ml/kg/TBSA [ Time Frame: 24 hours ]The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg/TBSA
- Total 48 hour resuscitation volume in ml/kg/TBSA [ Time Frame: 48 hours ]The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg/TBSA
- Hemodynamic instability [ Time Frame: 48 hours ]Severity and duration of hemodynamic instability during hours 0-48 postburn (norepinephrine equivalents)
- Metabolic acidosis [ Time Frame: 48 hours ]Severity and duration of metabolic acidosis (arterial lactate levels)
- Incidence of "rescue" (a) [ Time Frame: 48 hours ]Initiation of extracorporeal therapy (continuous renal replacement therapy or therapeutic plasma exchange
- Incidence of "rescue" (b) [ Time Frame: 48 hours ]Infusion of high-dose ascorbic acid (66 mg/kg/hr)
- Incidence of "rescue" (c) [ Time Frame: 24 hours ]Initiation of a continuous infusion of albumin
- Acute Respiratory Distress Syndrome [ Time Frame: 7 days ]Incidence of Acute Respiratory Distress Syndrome using Berlin Criteria
- Mechanical ventilation [ Time Frame: 28 days ]Ventilator free days
- Intensive Care Unit days [ Time Frame: 28 days ]Intensive Care Unit free days
- Multi-Organ Failure Assessment [ Time Frame: 7 days ]Sequential Organ Failure Assessment scores. Minimum score 1, maximum score 4. The higher the score the worse the outcome.
- Transfusion-Related Acute Lung Injury [ Time Frame: 72 hours ]Incidence of Transfusion-Related Acute Lung Injury, Type I or II.
- Thromboembolic events [ Time Frame: 7 days ]Incidence of venous thrombosis-embolic events (deep vein thrombosis or pulmonary embolism)
- Mortality [ Time Frame: throughout study completion, an average of 1 year ]In hospital mortality
- Patient reported outcomes [ Time Frame: 6 months ]Patient reported outcomes using the Patient Reported Outcomes Measurement Information System, Global 10. This scale10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. Higher scores equal a healthier patient.
- Syndecan-1 levels [ Time Frame: 48 hours ]Syndecan-1 level in ng/dl
- Cytokines [ Time Frame: 48 hours ]Cytokines
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18 years
- Weight > 40 kg
- Initial assessment of thermal injury size ≥ 20% TBSA
- Admitted to the burn center and enroll able within 8 hours of injury
- Expected to receive intravenous resuscitation fluids for at least 24 hours after injury
- Expected to live > 24 hours after injury
Exclusion Criteria:
- Chemical injury
- Deep electric injury
- Associated non-thermal injuries with estimated Injury Severity Score > 25
- Inability to obtain informed consent
- Decision not to treat due to injury severity or other factors
- Patient age > 65 years or < 18 years
- Presence of anoxic brain injury that is not expected to result in complete recover
- Patent already receiving plasma infusion, or judged to be likely to require plasma infusion
- Patent already receiving "rescue procedures" (albumin infusion, CRRT, TPE, or high-dose ascorbic acid)
- Existence of pre-morbid conditions: Congestive heart failure (NYHA Class IV); End-stage kidney disease (dialysis patient); Cirrhosis of the liver; Oxygen-dependent chronic obstructive pulmonary disease; Malignancy currently under treatment; Previous bilateral lower extremity amputations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681638
Contacts
| Contact: Monica Phillips, MBA | 210-884-3410 | monica@nattrauma.org | |
| Contact: Michelle Price, PhD | 210-455-8038 | michelle@nattrauma.org |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham Burn Center | |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Shannon Stephens 205-934-5890 swstephens@uabmc.edu | |
| Principal Investigator: Jan Jensen, MBBS, Phd | |
| United States, Louisiana | |
| The Blood Center | |
| Hammond, Louisiana, United States, 70403 | |
| Contact: Tiffany Head 958-340-2341 tpoirrier@thebloodcenter.org | |
| United States, Maryland | |
| University of Maryland School of Medicine | |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Rosemary Kozar, MD 410-328-3495 rkozar@som.umaryland.edu | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Sarah Folliard, BSN 615-936-2876 sarah.folliard@vumc.org | |
| Principal Investigator: Robel Beyene, MD | |
| United States, Texas | |
| University of Texas Southwestern | |
| Dallas, Texas, United States, 75390 | |
| Contact: Juan Nunez, PhD 214-648-0235 juna.nunez2@utsouthwestern.edu | |
| Principal Investigator: Benjamin Levi, MD | |
| U.S. Army Burn Center | |
| Fort Sam Houston, Texas, United States, 78234-6315 | |
| Contact: Elsa Coates, BSN 210-916-0990 elsa.c.coates.civ@mail.mil | |
| Sub-Investigator: James Bynum, PhD | |
| Principal Investigator: Leopoldo Cancio, MD | |
| University of Texas Medical Branch Shriners Burns Hospitals for Children | |
| Galveston, Texas, United States, 77550 | |
| Contact: Steven Wolf, MD 409-770-6607 swolf@utmb.edu | |
| Principal Investigator: Steven Wolf, MD | |
| United States, Washington | |
| University of Washington School of Medicine | |
| Seattle, Washington, United States, 98104-2499 | |
| Contact: Emily Eschelbach, BSN 206-774-3587 eschee13@uw.edu | |
| Sub-Investigator: Dagmar Amtmann, PhD | |
| Principal Investigator: Barclay Stewart, MD | |
Sponsors and Collaborators
Coalition for National Trauma Research
Cerus Corporation
Investigators
| Principal Investigator: | Leopoldo Cancio, MD | U.S. Army Burn Center |
| Responsible Party: | Coalition for National Trauma Research |
| ClinicalTrials.gov Identifier: | NCT04681638 |
| Other Study ID Numbers: |
CNTR-2020-001 CDMRP-DM190167 ( Other Grant/Funding Number: Department of Defense ) |
| First Posted: | December 23, 2020 Key Record Dates |
| Last Update Posted: | August 30, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Data will become available one year after initial results publication. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
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Lung Injury Lung Diseases Respiratory Tract Diseases Thoracic Injuries Wounds and Injuries |