Prehospital Treatment With Dried Plasma in Patients With Major Bleeding-A Prospective Randomised Controlled...

Area of Science:

• Emergency Medicine
• Trauma Care
• Blood Product Research

Background:

• Major hemorrhage is a leading preventable cause of death in prehospital settings.
• Logistical challenges hinder in-hospital plasma use, necessitating field-appropriate solutions.
• Dried plasma presents a viable option for remote and rural emergency medical services.

Purpose of the Study:

• To outline the statistical analysis plan for a trial evaluating dried plasma versus standard care in bleeding patients.
• To assess the impact of prehospital dried plasma on 24-hour survival rates.
• To investigate secondary outcomes including coagulopathy markers and transfusion volumes.

Main Methods:

• Prospective, randomized parallel trial (ClinicalTrials.gov: NCT07012863) involving adult patients with suspected bleeding.
• Ambulance randomization to dried plasma or standard care (crystalloids), stratified by region.
• Intention-to-treat analysis using Cox and regression models, with Bonferroni-Holm adjustment for 650 enrolled patients.

Main Results:

• Primary outcome: 24-hour survival rate.
• Secondary outcomes: markers of coagulopathy, transfusion volume, transport time impact.
• Statistical analysis will employ Cox regression, linear, and quantile regression.

Conclusions:

• This protocol ensures transparent and unbiased evaluation of prehospital dried plasma.
• Results may guide clinical practice and policy for civilian and military emergency care.
• Addresses an urgent need for effective field-applicable blood products in trauma management.