Whole Blood in Trauma Patients With Hemorrhagic Shock

Launched by FUNDACION CLINICA VALLE DEL LILI · Nov 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat trauma patients who are experiencing severe blood loss, known as hemorrhagic shock. Researchers want to compare two methods of providing blood transfusions: using whole blood (which includes all components of blood) versus using separate blood components like red blood cells, plasma, and platelets. The main goals are to see which method leads to lower death rates within 28 days and better overall health of the organs affected by the trauma.

To be eligible for this trial, participants need to be adults over 18 years old who are experiencing severe bleeding from trauma and are likely to need a large amount of blood transfusion. They must also be able to receive either whole blood or blood component therapy. However, certain patients are excluded, such as those with very severe injuries, those who have already received multiple blood transfusions, or pregnant individuals. If someone joins the study, they will receive one of the two types of blood treatment and will be monitored closely for their recovery and any changes in their health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients (\> 18 years)
• • Activating institutional trauma code for trauma patients with hemorrhagic shock.
• • Candidate for massive transfusion (Patient with an Assessment Blood Consumption (ABC) Score ≥ 2 or at the discretion of the treating physician)
• • Concurrent availability of whole blood or blood component therapy
• Exclusion Criteria:
• • More than 4 hours from trauma to hospital admission
• • More than 2 hours from hospital admission to randomization
• • Transfusion of more than one packed red blood cell unit prior to randomization.
• • Patients who have undergone surgery (laparotomy, thoracotomy, or sternotomy) before hospital admission.
• • In-extremis patients with devastating injuries (expected to die within 60 minutes).
• • Blood group other than to O or A and positive Rh factor
• • Severe traumatic brain injury in which neurosurgical intervention is futile (partial decapitation, massive intracranial hemorrhage, or transcranial gunshot wounds).
• • Burns over 20% of the total body surface area.
• • Suspected airway burn.
• • Cardiopulmonary resuscitation (CPR) before arrival at the ED.
• • CPR for more than 5 minutes before randomization.
• • Do not resuscitate order.
• • Incarcerated/prisoners.
• • Known pregnancy in the ED.
• • Patient or legal representative who refuse to participate in clinical research studies.