Thromboelastometry in Acute Hemorrhage Induced by Traumatic Injury of the Brain - a pilot study.

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00011559
• Date of registration: 13/01/2017
• Prospective Registration: Yes
• Primary sponsor: Institute for Research in Operative Medicine (IFOM)Private University Witten-Herdecke (UWH)
• Public title: Thromboelastometry in Acute Hemorrhage Induced by Traumatic Injury of the Brain - a pilot study.
• Scientific title: Thromboelastometry in Acute Hemorrhage Induced by Traumatic Injury of the Brain - a pilot study. - TAHITI-B
• Date of first enrolment: 01/02/2017
• Target sample size: 40
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00011559
• Study type: interventional
• Study design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: other
• Phase: N/A

Countries of recruitment

Belgium, Germany, Hungary, Spain

Contacts

• Name: Johannes Gratz
• Affiliation: Medizinische Universität WienUniversitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

• Name: Johannes Gratz
• Affiliation: Medical University of Vienna; Department of Anesthesiology, General Intensive Care and Pain Medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1.) Clinical diagnosis of severe TBI (GCS=8)
2.) Suspicion of clinically relevant hemorrhage
3.) Clinical indication for CT scan
4.) Presentation to the hospital within 24 hours after injury
Exclusion criteria: Severe pre-existing neurological disorder that would confound outcome asessements (according to CENTER-TBI)

Age minimum: None
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

S06
D68

Other coagulation defects

Intracranial injury

Intervention(s)

Group 1: Blood will be drawn to perform ROTEM® measurements (EXTEM and FIBTEM A5) as soon as possible after admission of a patient with severe TBI and suspicion of clinically relevant hemorrhage. These measurements will be used to guide the administration of hemostatic substances (tranexamix acid, fibrinogen or cryoprecipitate, platelet concentrate, prothrombin complex concentrate or fresh frozen plasma) in the included patients. The exact algorithm is described in the study protocol.

Primary Outcome(s)

The percentage of patients in whom the ROTEM® guided coagulation management algorithm has been started in regard to stepwise decision-making either in favor or against the suggested intervention, including action taken or the decision not to perform any intervention, according to EXTEM and FIBTEM A5 results within 60 minutes after admission of the patient to the hospital.

Secondary Outcome(s)

1.) Time to first ROTEM® results after admission and after blood sampling. 2.) Time from admission to administration of agents suggested by the algorithm. 3.) Time from the first ROTEM® results to administration of agents suggested by the algorithm. 4.) Adherence to the algorithm and capturing reasons for non-adherence. (N.B.: Adherence will be defined as decision-making according to the algorithm within 60 minutes after initiation of the algorithm. Exact dosing of agents administered will not be taken into account.) 5.) ROTEM® results at 60 minutes after initiation of the algorithm. 6.) Additional systemic haemostatic interventions. 7.) Clinical outcome data as captured in the CENTER-TBI CRF.

Source(s) of Monetary Support

CENTER-TBI, supported by the European Union 7th Framework Program (Project ID 602150) coordinated by Antwerp University Hospital

Ethics review

Status: Approved
Approval date: 05/08/2016
Contact:

[e-mail]

Ethik-Kommission an der Med. Fakultät der RWTH Aachen am Universitätsklinikum Aachen

[phone]

[e-mail]

Results

• Date Completed: 01/01/2018
• URL: http://drks.de/search/en/trial/DRKS00011559#studyResults