Effects of an Early Prehospital Administration of Tranexamic Acid on Hyperfibrinolysis in Multiple Trauma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperfibrinolysis
- Sponsor
- University of Göttingen
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Initial state of hyperfibrinolysis
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
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.
Investigators
Dr. med. Nils Kunze
Principal Investigator
University of Göttingen
Eligibility 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)
Outcomes
Primary Outcomes
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
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
- mortality(90 days)
- substitution of coagulation products(48 hours after hospital admission)
- length of stay intensive care unit (LOS ICU)(one year)
- length of hospital stay(one year)
- transfusion of packed red blood cells(48 hours)