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The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury

NCT04515420 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2020-08-17

No results posted yet for this study

Summary

Aim of the study

The investigators aim to establish:

* Whether noradrenaline (NA) infusion has a significant effect on coagulation and fibrinolysis in patients with severe traumatic brain injury (TBI).
* Whether disruption of haemostasis can be recorded with a computerized tomography (CT) scan.
* Whether there is a significant difference between the values of haemostasis parameters in the internal jugular vein and the radialis artery.

The hypotheses

1. In the early stage of treatment (1-3 hours), an increased formation of thrombin occurs in patients with severe isolated TBI that are treated with NA; consequently, platelet use increases in comparison with patients who don't need NA, as do coagulation factors and hyperfibrinolysis.
2. The concentration of NA correlates with thrombin formation and the correlation is stronger in higher doses of NA.
3. Thrombin formation will decrease more slowly in the group that will receive NA therapy in comparison to the group that will not receive NA therapy.

Conditions

  • Brain Injuries, Traumatic
  • Coagulopathy
  • Coagulation Defect; Acquired
  • Coagulation Defect; Bleeding
  • Fibrinolytic Hemorrhage, Acquired

Interventions

DRUG

noradrenaline

noradrenaline infusion

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-09-01
Completion
2022-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515420 on ClinicalTrials.gov