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Search / Trial NCT07097337

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

Point Of Care Fibrinogen Trauma Induced Coagulopathy Fibrinogen Suppletion Fibrinogen

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.

Locations

Patients applied

0 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