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

Mortality Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938768
• Other study ID #: ZARI-NK-2013-02
• Status: Completed
• Phase: N/A
• First received: September 5, 2013
• Last updated: November 30, 2015
• Start date: November 2013
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Haemorrhage
• Hyperfibrinolysis
• Mortality
• Multiple Trauma

Locations

Country	Name	City	State
Germany	University Medical Center Göttingen	Goettingen	Lower Saxony

Sponsors (2)

Lead Sponsor	Collaborator
University of Göttingen	Tem International GmbH, München, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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, Mejía-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. — View Citation

Schöchl H, Frietsch T, Pavelka M, Jámbor 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial state of hyperfibrinolysis	State of hyperfibrinolysis quantified by thromelastometry and PAP-Complex (Plasmin-Antiplasmin-Complex) from a blood sample taken a soon as possible on the scene	Minutes after arrival on the scene	No
Primary	State of hyperfibrinolysis on hospital admission	State of hyperfibrinolysis quantified by thrombelastometry and PAP-Complex from a blood sample taken as soon as possible after hospital arrival	minutes to hours after incident	No
Secondary	transfusion of packed red blood cells	units of packed RBC units transfused within 48 hours after hospital admission	48 hours	No
Secondary	substitution of coagulation products	number and type of coagulation products given within 48 hours after hospital admission	48 hours after hospital admission	No
Secondary	length of stay intensive care unit (LOS ICU)	length of the first ICU stay	one year	No
Secondary	length of hospital stay	length of stay in the acute care hospital (not rehabilitation facilities)	one year	No
Secondary	mortality	dead within 90 days after hospital admission	90 days	No

External Links

•   Homepage of the center for anaesthesiology, emergency and intensive care medicine of the university medical center Göttingen