Status:
WITHDRAWN
Coagulation Activation by Hyperosmolar Agents in Intracranial Hypertension
Lead Sponsor:
Neuromed IRCCS
Conditions:
Intracranial Hypertension
Cerebral Edema
Eligibility:
All Genders
18-80 years
Brief 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...
Detailed Description
Osmotherapy is commonly used in the treatment of intracranial hypertension (ICH) due to a variety of causes, including head trauma, intracranial neoplasia, infection or hemorrhage, and status epilepti...
Eligibility Criteria
Inclusion
- Indication to osmotic therapy for cerebral edema / non-traumatic intracranial hypertension
- Age 18 - 80 years
- Body temperature between 35.5 ° C and 37.5 °C
Exclusion
- Congenital or acquired disorders of hemostasis
- Clinical history of abnormal bleeding
- Hematologic or Renal diseases (acute or chronic renal failure II-III stage)
- Chronic or recent therapy with antiplatelet and/or anticoagulants
- Taking corticosteroids or nonsteroidal anti-inflammatory drugs (less than 4 weeks)
- Administration of macromolecular vascular filling solutions (less than 4 weeks)
- History of recent venous / arterial thromboembolic disease (less than three months)
- Moderate-severe liver dysfunction
- Anemia (hb \<10 mg/dl)
- Recent transfusions (less than three months)
- Hyponatremia (Na \<135 meq/l)
- Hypernatremia (Na\> 155 meq/l)
Key Trial Info
Start Date :
December 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03409237
Start Date
December 3 2020
End Date
December 31 2021
Last Update
November 19 2020
Active Locations (1)
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1
IRCCS INM Neuromed, Department of Epidemiology and Prevention
Pozzilli, IS, Italy, 86077