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Trauma Associated Bleeding: Effectiveness of an Early Coagulation Support Protocol

NCT03354559 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 235

Last updated 2017-11-28

No results posted yet for this study

Summary

In severe trauma patients, uncontrolled bleeding is a major cause of death, partly caused by trauma-induced coagulopathy (TIC).TIC represents a severe post-traumatic complication associated with increased transfusion requirements and worsened mortality. Fibrinolysis is a central part of the TIC process. Massive Transfusion Protocols (MTPs) were introduced as part of damage control resuscitation, with the aim to facilitate rapid blood product release and to increase adherence to hemostatic resuscitation, In 2013, the Italian Trauma Centers Network (TUN) developed a new treatment algorithm providing early coagulation support (ECS) to control coagulopathy and hemorrhage in major trauma patients with a clinically relevant bleeding risk. The protocol includes the use of fibrinogen concentrate and RBC during initial resuscitation, and the early use of viscoelastic techniques when available (thromboelastometry ROTEM® or thromboelastography TEG).

The aim of this multicenter, before and after study was to assess the effects of a new ECS protocol compared to the standard MTP in terms of blood products' consumption and clinical outcome.

Conditions

  • Major Trauma

Sponsors & Collaborators

  • San Camillo Hospital, Rome

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2014-12-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03354559 on ClinicalTrials.gov