Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
Launched by ERASMUS MEDICAL CENTER · Jul 24, 2025
Trial Information
Current as of September 08, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new, faster blood test to measure fibrinogen—a protein that helps blood clot—in adults who have suffered serious injuries and are bleeding heavily in the emergency room. When people have major trauma, their blood sometimes doesn’t clot properly, which can make bleeding worse and harder to control. Right now, testing fibrinogen levels takes a long time, which can delay treatment. This study wants to see if a quick, bedside test can be done during emergency care to help doctors decide more quickly who really needs extra fibrinogen to stop bleeding.
The study will include adults (16 years or older) who come to the emergency department with major injuries and ongoing bleeding, and who require a special blood transfusion process called a Massive Transfusion Protocol. Participants won’t have extra blood taken because the test uses a small sample from routine blood draws. The new test results won’t be used to guide treatment during the study; instead, the research team will check later whether having quick results might have helped doctors make better decisions or improved patient outcomes. If successful, this test could lead to faster, more personalized care, reduce unnecessary treatments, and improve survival for trauma patients.
Gender
ALL
Eligibility criteria
- • Population (base) Adult trauma patients will be identified as follows: (1) by the trauma team leader on admission to the ED or (2) by the research team personnel following a massive transfusion protocol activation. Patients will be assessed for eligibility to enter the trial according to the criteria set out below. If patients are eligible for entry into the study following initial screening, they will be enrolled automatically under deferred consent. Patients will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the exclusion criteria detailed below.
- • Inclusion criteria
- To be eligible to participate in this study, a subject must meet the following criteria:
- • The participant is judged to be an adult (according to the attending clinician, e.g. 16 years or older) and has sustained traumatic injury
- • The participant is deemed by the attending clinician to have on-going active hemorrhage
- • The major hemorrhage protocol (MTP) is activated or this patient and transfusion is initiated
- • Exclusion criteria
- * A potential subject who meets any of the following criteria will be excluded from participation in this study:
- • The participant has been transferred from another hospital
- • The trauma team leader deems the injuries incompatible with life
About Erasmus Medical Center
Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Caroline van der Marel, MD, PhD
Study Director
Erasmus Medical Center
Niki A. Ottenhof, MD, PhD
Principal Investigator
Erasmus Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported