Phase I study of intraventricular recombinant tissue plasminogen activator for treatment of posthaemorrhagic hydrocephalus

Arch Dis Child Fetal Neonatal Ed. 1996 Jul;75(1):F20-6. doi: 10.1136/fn.75.1.f20.

Abstract

Aim: Phase I study to evaluate intraventricular fibrinolytic treatment with recombinant tissue plasminogen activator (tPA) as a method of clearing blood from the cerebrospinal fluid, and thus preventing permanent hydrocephalus.

Methods: Twenty two preterm infants, aged 7 to 26 days, with progressive posthaemorrhagic ventricular dilatation (ventricular width > 4 mm over 97th centile) received one to five intraventricular bolus injections of 1.0 mg or 0.5 mg tPA at intervals of one to seven days.

Results: The mean cerebrospinal fluid concentration of tPA 24 hours after 1 mg was 1860 micrograms/ml. The half life of tPA in cerebrospinal fluid was about 24 hours. Twenty one (95%) infants survived, 12 (55%) without shunt surgery. One infant had secondary intraventricular haemorrhage.

Conclusion: Intraventricular tPA resulted in survival without a shunt for most of the infants, but with some risk. Failure may have been due to plasminogen deficiency, an inhibitor, or late intervention.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cerebral Hemorrhage / cerebrospinal fluid
  • Cerebral Hemorrhage / drug therapy
  • Half-Life
  • Humans
  • Hydrocephalus / cerebrospinal fluid
  • Hydrocephalus / drug therapy*
  • Infant, Newborn
  • Infant, Premature
  • Infant, Premature, Diseases / cerebrospinal fluid
  • Infant, Premature, Diseases / drug therapy*
  • Injections, Intraventricular
  • Plasminogen Activators / administration & dosage
  • Plasminogen Activators / cerebrospinal fluid
  • Plasminogen Activators / therapeutic use*
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / therapeutic use
  • Tissue Plasminogen Activator / administration & dosage
  • Tissue Plasminogen Activator / cerebrospinal fluid
  • Tissue Plasminogen Activator / therapeutic use*

Substances

  • Recombinant Proteins
  • Plasminogen Activators
  • Tissue Plasminogen Activator