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High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury

U

University Hospital, Angers

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Severe Head Injury

Treatments

Drug: human serum albumin

Study type

Interventional

Funder types

Other

Identifiers

NCT00152685
CP 02-04

Details and patient eligibility

About

Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • severe head injury (GCS < 9) Next of kin informed consent

Exclusion criteria

  • Cranio cerebral wound Pregnancy Hypoxemia (PaO2/FiO2< 300 mmHg) Blood loss > 1/2 blood mass Renal or cardiac failure,uncontrolled hypertension Head injury dating from more than 24 hours at the time of inclusion

Trial contacts and locations

3

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Central trial contact

Ter Minassian Aram, MD, PhD

Data sourced from clinicaltrials.gov

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