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

U

University of Göttingen

Status

Completed

Conditions

Mortality
Hyperfibrinolysis
Haemorrhage

Study type

Observational

Funder types

Other

Identifiers

NCT01938768
ZARI-NK-2013-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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)

Trial design

110 participants in 2 patient groups

Tranexamic acid
Description:
patients with multiple trauma who received tranexamic acid on the scene
Non tranexamic acid
Description:
patients with multiple trauma who did not receive tranexamic acid on the scene

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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