Pentoxyfilline for Reduction of Delayed Cerebral Ischaemia after Aneurysmal Subarachnoid Haemorrhage: a pilot study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001932257

Acronym

PRECISE-SAH

Enrollment

Registered

2018-11-28

Start date

2022-12-01

Completion date

2024-09-27

Last updated

2022-09-19

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

Conditions

None listed

Brief summary

Pentoxifylline is a medication that decreases the viscosity of blood and helps red blood cells travel better through narrow blood vessels. Aneurysmal subarachnoid haemorrhage is a type of stroke that can be complicated by a second type of stroke called delayed cerebral ischaemia. This is a pilot, randomized controlled study to determine if pentoxifylline when used in aneurysmal subarachnoid haemorrhage decreases the rate of delayed cerebral ischaemia.

Interventions

Pentoxifylline, 200mg enterally by mouth or nasogastric tube, every 4 hours, for 21 days after aneurysmal subarachnoid haemorrhage. Adherence will be checked by reviewing the electronic medication prescribing chart to see if the patient has received the medication.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adults (>18yr of age) 2. Admitted to Intensive Care Unit 3. Diagnosis of aneurysmal subarachnoid haemorrhage (aSAH). 4. High-grade aSAH with high chance of developing vasospasm: WFNS grade 4 or 5 regardless of Fisher score (VASOGRADE: Red). 5. Patients found to have vasospasm on screening angiography done within first week post ictus regardless of aSAH classification. 6. Within 4 days of ictus. 7. Culprit aneurysm that has been secured with either Interventional Neuroradiology (coiling) or neurosurgery (clipping) 8. Assessment by proceduralist (INR or neurosurgeon) that the aneurysm has been sufficiently secured.

Exclusion criteria

1. SAH not from aneurysm (trauma, AVM, etc.). 2. Coexistent neurological vascular injury (extradural, subdural haemoatoma). 3. Patients on antiplatelet medications or anticoagulation (NOAC, heparin, etc.) including those that receive a stent 4. Expected to die within this admission. 5. Allergy to pentoxifylline or xanthines. 6. Unable to use enteral route. 7. Pregnant or breastfeeding patients. 8. Liver dysfunction with AST and/or ALT >500 9. Renal dysfunction with eGFR <30ml/hr

Outcome results