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Coagulation Activation by Hyperosmolar Agents in Intracranial Hypertension

NCT03409237 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-11-19

No results posted yet for this study

Summary

Osmotherapy consists in the therapeutic use of osmotically active substances with the aim of reducing the volume and therefore the intracranial pressure. It therefore represents an essential component in the clinical management of cerebral edema and intracranial hypertension, whether they are a consequence of head trauma, ischemic or hemorrhagic stroke, and neoplasm or neurosurgical procedures.

The current study aims at evaluating in vivo the effects on haemostasis parameters of hypertonic saline solutions at different concentration, as compared to mannitol, in patients with neuroradiological signs (CT / MRI) of cerebral edema / non-traumatic intracranial hypertension.

Conditions

  • Intracranial Hypertension
  • Cerebral Edema

Interventions

DRUG

Mannitol

Therapy is administered according to the clinical gold standard and until reaching and maintaining serum sodium levels between 145 e 155 meq/l and an osmolarity \<320.

DRUG

Hypertonic saline solution

Therapy is administered according to the clinical gold standard and until reaching and maintaining serum sodium levels between 145 e 155 meq/l and an osmolarity \<320.

Sponsors & Collaborators

  • Neuromed IRCCS

    lead OTHER

Principal Investigators

  • Licia Iacoviello, MD, PhD · IRCCS Neuromed

  • Fulvio Aloj, MD · IRCCS Neuromed

Eligibility

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

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2021-07-01
Completion
2021-12-31

Countries

  • Italy

Study Locations

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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 NCT03409237 on ClinicalTrials.gov