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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011559

Enrollment

Registered

2017-01-13

Start date

2017-02-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S06 D68

Interventions

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. Thes

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: Severe pre-existing neurological disorder that would confound outcome asessements (according to CENTER-TBI)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Belgium, Germany, Hungary, Spain

Contacts

Public ContactJohannes Gratz

Medizinische Universität WienUniversitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

johannes.gratz@meduniwien.ac.at+43-40400-41500

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026