Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 epilepticus. The principle goal of osmotherapy is to shift fluid from the intracellular into the extracellular compartment using intravenous hyperosmolar agents, thereby reducing brain edema and improving cerebral perfusion pressure. Although 10-20% mannitol is considered the gold standard hyperosmolar agent in the treatment of ICH, mannitol-induced osmotic diuresis may cause hypovolemia and reduction in cerebral perfusion pressure. In recent years, 3.0-7.5% hypertonic saline (HTS) has gained popularity in the treatment of ICH as it has less pronounced diuretic effects and therefore does not cause hypovolemia. Indeed, in the face of hypovolemic shock and traumatic brain injury, HTS provides the advantage of volume expansion, restoring adequate cerebral perfusion pressures, and reducing brain edema, which makes it superior to mannitol in trauma patients with shock. Both mannitol and HTS have been shown to interfere with whole blood coagulation and platelet function. This is in part due to dilutional coagulopathy. Furthermore, 7.2% HTS may directly disturb both fibrin formation and platelet function, and mannitol may interfere with coagulation by reducing clot strength. In addition, hyperosmolarity is supposed to lead to impairment of both whole blood coagulation and platelet function . In consequence, the safety of using these agents in patients with ICH and intracranial hemorrhage remains unclear. Previous in vitro studies in humans have demonstrated anticoagulant effects of both mannitol and HTS, although one clinical study failed to demonstrate any negative effect on hemostasis using either solution in patients undergoing elective intracranial surgery. However, in vivo studies in a clinical setting are lacking. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03409237
Study type Observational
Source Neuromed IRCCS
Contact
Status Withdrawn
Phase
Start date December 3, 2020
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT06367868 - Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring N/A
Completed NCT04488874 - Sodium Lactate and Brain Relaxation (LSD) Phase 3
Not yet recruiting NCT04211064 - Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter N/A
Completed NCT00571623 - Automated Chest Physiotherapy to Improve Outcomes in Neuro N/A
Recruiting NCT00437814 - Effect of Ketamine (Ketalar) on Intracranial Pressure N/A
Recruiting NCT03212976 - Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure N/A
Withdrawn NCT02558309 - Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure N/A
Terminated NCT00795587 - Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring Phase 4
Completed NCT00447018 - Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure Phase 4
Not yet recruiting NCT05593380 - The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH N/A
Completed NCT03364634 - Intracranial Pressure After Decompressive Craniectomy N/A
Unknown status NCT02773901 - Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement N/A
Terminated NCT01973764 - Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System N/A
Terminated NCT00319345 - Sodium-Lactate and Traumatic Brain Injury Phase 2/Phase 3
Recruiting NCT04459806 - Intracranial PrEssure Time dOse (ImPETO)
Completed NCT00239525 - 3-D Transcranial Ultrasound Analysis Study N/A
Completed NCT05946200 - Optic Nerve Sheath Diameter in Low-flow and Normal-flow Rate Anesthesia N/A
Completed NCT03957837 - Optical Nerve Sheath Changes During Head Down Laparoscopy
Not yet recruiting NCT05818371 - Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting N/A
Completed NCT04429477 - Cerebral Compliance Impairment in COVID-19