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Phase 2 N=30 Randomized Double-blind Treatment

Induced Suppression of Platelets Activity in Aneurysmal SAH Management (iSPASM)

Subarachnoid Hemorrhage, Aneurysmal

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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