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

Not Applicable

• Conditions: S06; D68; Intracranial injury; Other coagulation defects

• Registration Number: DRKS00011559
• Lead Sponsor: Institute for Research in Operative Medicine (IFOM)Private University Witten-Herdecke (UWH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-13
• Study Completion: 2018-01-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.