Clinical Trials Logo

Clinical 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. 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) 1. decrease in the amount of blood transfused in the operating room 2. decrease in the amount of blood transfused during hospitalization 3. 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 4. decrease the hospital length of stay, lung dysfunction, infections, and mortality


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05063409
Study type Interventional
Source Shriners Hospitals for Children
Contact
Status Completed
Phase N/A
Start date September 2010
Completion date February 28, 2020

See also
  Status Clinical Trial Phase
Completed NCT02210208 - A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients. N/A
Withdrawn NCT02241941 - Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury Phase 4
Completed NCT03730688 - Non-invasive Limb Compartment Pressure Measurement N/A
Recruiting NCT04368117 - STAT: Standard Therapy Plus Active Therapy N/A
Terminated NCT01773083 - Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma Phase 3
Completed NCT02092701 - Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period N/A
Completed NCT02145130 - Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects Phase 1
Completed NCT01618630 - Amino Acid Supplementation in Recovery From Severe Burns N/A
Recruiting NCT05876442 - Efficacy of EPSW Plus HILT on Carpal Tunnel Syndrome Post Burn Injury N/A
Completed NCT04417439 - The Effect of Acute Phase Treatment Approaches on Creatine Kinase and the Musculoskeletal System in Different Types of Burns
Completed NCT02417779 - Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy N/A
Completed NCT02417818 - Cutaneous Microcirculation After Plasma Therapy N/A
Completed NCT02417805 - Cutaneous Microcirculation After Remote Ischemic Preconditioning N/A
Not yet recruiting NCT06263296 - Smartphone Assisted Self-management Education for Adult Burn Patient at Aftercare N/A
Completed NCT01404026 - Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Due to Burn Injury N/A
Completed NCT03204669 - Trace Element Repletion Following Severe Burn Injury N/A
Recruiting NCT04947449 - Potential Benefits of Laser Treatment on Skin Blood Flow and Sweating in Burn Survivors
Recruiting NCT02189538 - Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients N/A
Completed NCT01795079 - Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury N/A
Recruiting NCT01499264 - Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial Phase 3