Clinical trial NCT01938768: Effects of an Early Prehospital Administration of Tranexamic Acid on Hyperfibrinolysis in Multiple Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperfibrinolysis
Haemorrhage
Mortality
Keywords: Multiple trauma
Polytrauma
Hyperfibrinolysis
Tranexamic acid
Thrombelastometry
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: Tem International GmbH, München, Germany
First posted: 2013-09-10
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited by emergency physicians on the scene by taking a blood sample for thrombelastometry.

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.

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)

Primary outcomes:
measure: Initial state of hyperfibrinolysis
timeFrame: Minutes after arrival on the scene
measure: State of hyperfibrinolysis on hospital admission
timeFrame: minutes to hours after incident
Secondary outcomes:
measure: transfusion of packed red blood cells
timeFrame: 48 hours
measure: substitution of coagulation products
timeFrame: 48 hours after hospital admission
measure: length of stay intensive care unit (LOS ICU)
timeFrame: one year
measure: length of hospital stay
timeFrame: one year
measure: mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: University Medical Center Göttingen
state: Lower Saxony
Study officials:
affiliation: University of Goettingen
name: Quintel Michael, Prof. Dr.
role: STUDY_CHAIR
affiliation: University of Goettingen
name: Roessler Markus, PD Dr.
role: STUDY_DIRECTOR
References:
citation: Schochl H, Frietsch T, Pavelka M, Jambor C. Hyperfibrinolysis after major trauma: differential diagnosis of lysis patterns and prognostic value of thrombelastometry. J Trauma. 2009 Jul;67(1):125-31. doi: 10.1097/TA.0b013e31818b2483.
citation: CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
citation: CRASH-2 collaborators; Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, Gando S, Guyatt G, Hunt BJ, Morales C, Perel P, Prieto-Merino D, Woolley T. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2. doi: 10.1016/S0140-6736(11)60278-X.
citation: Kunze-Szikszay N, Krack LA, Wildenauer P, Wand S, Heyne T, Walliser K, Spering C, Bauer M, Quintel M, Roessler M. The pre-hospital administration of tranexamic acid to patients with multiple injuries and its effects on rotational thrombelastometry: a prospective observational study in pre-hospital emergency medicine. Scand J Trauma Resusc Emerg Med. 2016 Oct 10;24(1):122. doi: 10.1186/s13049-016-0314-4.