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

NCT ID: NCT01938768

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-10-31

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.

Conditions

Hyperfibrinolysis; Haemorrhage; Mortality

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tranexamic acid

patients with multiple trauma who received tranexamic acid on the scene

No interventions assigned to this group

Non tranexamic acid

patients with multiple trauma who did not receive tranexamic acid on the scene

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tem International GmbH, München, Germany

UNKNOWN

Sponsor Role: collaborator

University of Göttingen

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Nils Kunze

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quintel Michael, Prof. Dr.

Role: STUDY_CHAIR

University of Goettingen

Roessler Markus, PD Dr.

Role: STUDY_DIRECTOR

University of Goettingen

Locations

University Medical Center Göttingen

Göttingen, Lower Saxony, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 19590321 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20554319 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21439633 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27724970 (View on PubMed)

Other Identifiers

ZARI-NK-2013-02

Identifier Type: -

Identifier Source: org_study_id