Skip to main content
OpenTrials
Completed

NCT Number: NCT01938768

Effects of an Early Prehospital Administration of Tranexamic Acid on Hyperfibrinolysis in Multiple Trauma

Severe external and internal bleedings are common in multiple trauma patients. Uncontrollable blood loss is the cause for about one third of all trauma deaths. A number of blood clotting mechanisms are known to be triggered by major blood losses. These mechanisms shall secure the organisms from loosing even more blood. To avoid an overshooting clotting behavior, inhibiting mechanisms occur as well. An important inhibiting (or fibrinolytic) mechanism is the fibrinolysis that is based on the conversion of plasminogen to plasmin. In severe bleeding situations this mechanism tends to overshoot and therewith contributes to the severity of the bleeding. This phenomena is called hyperfibrinolysis and is found in approximately one third of all multiple trauma patients. Mortality rates are increased in these patients. Tranexamic acid is an antifibrinolytic drug that inhibits the conversion from plasminogen to plasmin and therefore is able to limit the effects hyperfibrinolysis. A large study showed positive influence of tranexamic acid on mortality rates and blood loss in severely injured patients, when it was administered in an early clinical setting. In this study we want to answer the question wether a hyperfibrinolysis can be seen in an early prehospital (on the scene) setting and how it is influenced by an early prehospital administration of tranexamic acid.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

About this study

In patients suffering from multiple trauma the initially responding emergency physician on the scene will take a blood sample for thrombelastometry immediately after i.v. access is established. According to the initial trauma life support protocols a number of patients will receive a dose of tranexamic acid during the initial treatment on the scene or during transport to the hospital. A second blood sample will be taken after arrival in the resuscitation area of the hospital. Thrombelastometric measurements will be performed with both blood samples and the extent of hyperfibrinolysis in both samples will be compared. In a second step the outcome of the patients who received tranexamic acid on the scene will be compared to those who did not receive the drug before reaching hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multiple trauma ISS > 15
  • Age > 18 years

Exclusion criteria

  • No informed consent
  • Inclusion to an interventional clinical trial
  • Death of the patient on the scene or before the hospital was reached
  • Delayed thrombelastometric measurement (> 4 hours)

Treatment and study plan

Primary outcomes

  1. Initial state of hyperfibrinolysis

    Time frame: Minutes after arrival on the scene

    State of hyperfibrinolysis quantified by thromelastometry and PAP-Complex (Plasmin-Antiplasmin-Complex) from a blood sample taken a soon as possible on the scene

  2. State of hyperfibrinolysis on hospital admission

    Time frame: minutes to hours after incident

    State of hyperfibrinolysis quantified by thrombelastometry and PAP-Complex from a blood sample taken as soon as possible after hospital arrival

Secondary outcomes

  1. transfusion of packed red blood cells

    Time frame: 48 hours

    units of packed RBC units transfused within 48 hours after hospital admission

  2. substitution of coagulation products

    Time frame: 48 hours after hospital admission

    number and type of coagulation products given within 48 hours after hospital admission

  3. length of stay intensive care unit (LOS ICU)

    Time frame: one year

    length of the first ICU stay

  4. length of hospital stay

    Time frame: one year

    length of stay in the acute care hospital (not rehabilitation facilities)

  5. mortality

    Time frame: 90 days

    dead within 90 days after hospital admission

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Collaborators

  • Tem International GmbH, München, Germany

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2013
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.