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

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ClinicalTrials.gov Identifier: NCT01938768
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
Tem International GmbH, München, Germany
Information provided by (Responsible Party):
Dr. med. Nils Kunze, University of Göttingen

Brief Summary:
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.

Condition or disease
Hyperfibrinolysis Haemorrhage Mortality

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Tranexamic acid
patients with multiple trauma who received tranexamic acid on the scene
Non tranexamic acid
patients with multiple trauma who did not receive tranexamic acid on the scene



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited by emergency physicians on the scene by taking a blood sample for thrombelastometry.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938768


Locations
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Germany
University Medical Center Göttingen
Goettingen, Lower Saxony, Germany, 37075
Sponsors and Collaborators
University of Göttingen
Tem International GmbH, München, Germany
Investigators
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Study Chair: Quintel Michael, Prof. Dr. University of Goettingen
Study Director: Roessler Markus, PD Dr. University of Goettingen

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. med. Nils Kunze, Principal Investigator, University of Göttingen
ClinicalTrials.gov Identifier: NCT01938768     History of Changes
Other Study ID Numbers: ZARI-NK-2013-02
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Dr. med. Nils Kunze, University of Göttingen:
Multiple trauma
Polytrauma
Hyperfibrinolysis
Tranexamic acid
Thrombelastometry

Additional relevant MeSH terms:
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Hemorrhage
Multiple Trauma
Pathologic Processes
Wounds and Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants