The effect of Papaverine Hydrochloride on the metabolism and oxygenation of the brain, in patients suffering severe cramps of the cerebral vessels due to severe bleeding from an aneurysm

Influence of intra-arterial cerebral Papaverine Hydrochloride on cerebral glucose, lactate, pyruvate, glycerol, and glutamate concentrations, cerebral oxygenation, angiographic vasospasm, delayed stroke rates, and neurologic outcome in patients suffering life-threatening post-subarachnoid hemorrhage cerebral vasospasm irresponsive to hyperdynamic treatment.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023878-40-AT

Enrollment

Registered

2011-12-05

Start date

2011-12-22

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To demonstrate the influence of intra-arterial cerebral Papaverine Hydrochloride on cerebral glucose, lactate, pyruvate, glycerol, and glutamate concentrations and cerebral oxygenation in patients suffering severe post-subarachnoid hemorrhage cerebral vasospasm

Interventions

Trade Name: Papaverin-HCL 2.5% Product Name: Papaverin-HCL 2,5% Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient age > 18 yrs. Aneurysmal SAH Saccular and fusiform cerebral aneurysm Aneurysm treated by surgery or embolisation Severe post SAH VSP irresponsive to hyperdynamic therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Intracranial hypertension obviating patient transport Delayed VSP related strokes on cerebral CT scans

Design outcomes

Primary

Measure	Time frame
Main Objective: o demonstrate the influence of intra-arterial cerebral Papaverine Hydrochloride on cerebral glucose, lactate, pyruvate, glycerol, and glutamate concentrations and cerebral oxygenation in patients suffering severe post-SAH cerebral VSP; Secondary Objective: To assess safety and tolerability of intra-arterial cerebral Papaverine Hydrochloride in patients with severe post-SAH VSP. To asses the effect of intra-arterial cerebral Papaverine Hydrochloride on angiographic vasospasm, delayed ischemic stroke rates, and neurologic outcome. ; Primary end point(s): Increases in cerebral glucose concentrations Reduction of cerebral lactate concentrations Reduction of cerebral lactate/pyruvate ratios Reduction of cerebral glutamate concentrations Reduction of cerebral glycerol concentrations Improved cerebral oxygenation ;Timepoint(s) of evaluation of this end point: within three hours after Papaverine administration	—

Measure

Time frame

Main Objective: o demonstrate the influence of intra-arterial cerebral Papaverine Hydrochloride on cerebral glucose, lactate, pyruvate, glycerol, and glutamate concentrations and cerebral oxygenation in patients suffering severe post-SAH cerebral VSP; Secondary Objective: To assess safety and tolerability of intra-arterial cerebral Papaverine Hydrochloride in patients with severe post-SAH VSP. To asses the effect of intra-arterial cerebral Papaverine Hydrochloride on angiographic vasospasm, delayed ischemic stroke rates, and neurologic outcome. ; Primary end point(s): Increases in cerebral glucose concentrations Reduction of cerebral lactate concentrations Reduction of cerebral lactate/pyruvate ratios Reduction of cerebral glutamate concentrations Reduction of cerebral glycerol concentrations Improved cerebral oxygenation ;Timepoint(s) of evaluation of this end point: within three hours after Papaverine administration

—

Secondary

Measure	Time frame
Secondary end point(s): Reversal of angiographic VSP Incidence of delayed ischemic strokes Neurologic outcome (GOS, mRS) ;Timepoint(s) of evaluation of this end point: 1 day, 1 month, 3 month	—

Countries

Austria

Contacts

Public ContactNeurosurgery, AKH Wien

Medical University Vienna

00431404002565

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026