Phase 2
N=30
Induced Suppression of Platelets Activity in Aneurysmal SAH Management (iSPASM)
Subarachnoid Hemorrhage, Aneurysmal
Bottom Line
View on ClinicalTrials.gov: NCT03691727 ↗Enrolled (actual)
30
Serious AEs
100.0%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants With Intracranial Hemorrhage (Symptomatic and Asymptomatic) — 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- tirofiban hydrochloride (AGGRASTAT®) (Drug); MRI (Diagnostic_test); Neurological Exam (Diagnostic_test); Questionnaires (Behavioral); Vital Signs (Diagnostic_test); Standard of Care Treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- David Hasan
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Intracranial Hemorrhage (Symptomatic and Asymptomatic) |
2; 1 | — |
| PRIMARY Number of Participants With Delayed Cerebral Ischemia /Clinical Vasospasm |
1; 4 | — |
Summary
This is a phase 1/2a, randomized, double blind, single-center study comparing standard care alone to standard care with Aggrastat in patients diagnosed with aneurysmal subarachnoid hemorrhage.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 and ≤ 85 years
- Hunt and Hess scale ≤ 4 at time of admission or following EVD placement.
- CT showing modified Fisher grade 1-4 aSAH on admission.
- The Modified Fisher CT rating scale: Grade 1 (minimal or diffuse thing SAH without IVH); Grade 2 (minimal or thin SAH with IVH), Grade 3 (thick cisternal clot without IVH), Grade 4 (thick cisternal clot with IVH)
- Placement of EVD on admission.
- Diagnosis of aSAH occurred 24 post embolization.
- Multiple aneurysms that may have been untreated and a potential etiology for rupture.
- Femoral arteriotomy stick above the inferior epigastric artery OR angiographic, CT, or clinical evidence of an arteriotomy related retroperitoneal hematoma or large flank hematoma. A stable groin hematoma is not an exclusion.
- Thrombocytopenia (platelet count less than 100, 000 - assuming clumping has been ruled out as a cause), confirmed active disseminated intravascular coagulation (DIC) at the time of enrollment OR a documented history of coagulopathy or bleeding diathesis.
- New parenchymal hemorrhage or new infarction larger the 15cc in volume (clinically significant), or worsening midline shift as seen on the post-coiling, pre-enrollment head CT when compared to baseline admission head CT. New hyperdensity on CT scan related to contrast staining is not an exclusion.
- Patient developed SAH-induced cardiac stunning prior to enrollment, with an ejection fraction 2 x normal.
- Creatinine clearance 150 kg (due to the lack of safety data)
- 2 or more passes for the ventricular catheter at time of placement.
Data sourced from ClinicalTrials.gov (NCT03691727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.