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Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods. (TOH-HTIC)

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Civil Hospices of Lyon

Status

Completed

Conditions

Liver Transplantation

Treatments

Device: Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT02695823
69HCL15_0483

Details and patient eligibility

About

Acute or chronic liver failure (fulminant hepatitis or advanced cirrhosis) disrupts brain physiology. Beyond classical hepatic encephalopathy, intracranial hypertension may occur.During liver transplantation (LT) surgery, many factors can lead to cerebral assault. In addition, intracranial hypertension measured with invasive methods has been described in certain phases of LT, especially at the time of reperfusion.

The invasive monitoring of the intracranial pressure is not used in these patients, due to a high risk of infection and bleeding. The non-invasive monitoring of intracranial pressure has been widely developed in recent years : transcranial doppler and recently ultrasound of the optic nerve sheath (ONSD) allow an effective detection of intracranial hypertension.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients ≥ 18 years
  • Patients who underwent orthotopic liver transplantation
  • Patients who have received clear information and not opposed to participate in the study
  • Patients affiliated to a social security scheme or similar
  • Patients not undergoing a measure of legal protection

Exclusion criteria

  • Opposition to participation in the study
  • Patients < 18 years
  • Pregnant women or breastfeeding
  • Deprived of individual liberty
  • Non-affiliated to a social security scheme
  • Known ophthalmic pathology: untreated cataracts, glaucoma

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

29 participants in 1 patient group

Patients undergoing liver transplantation
Experimental group
Treatment:
Device: Ultrasound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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