Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage

NCT01878136 | Withdrawn Phase 1 DMC

• 1 other identifier: 13011803
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the hypothesis that the administration of intraventricular tPA reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent hydrocephalus in patients with aneurysmal subarachnoid hemorrhage.

Conditions

Subarachnoid Hemorrhage; Cerebral Vasospasm; Cerebral Aneurysm; Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Composite Primary Outcome

  The composite primary outcome will consist of the rates of ventriculoperitoneal shunt (VPS) placement, clinically significant vasospasm, and death. VPS placement serves as surrogate measure of hydrocephalus. These outcomes will be measured during the patient's hospitalization.

  1-60 days after SAH

Secondary Outcomes (2)

• Rate of new intracranial hemorrhage

  1-14 days after SAH

• Rate of intracranial infection

  1-14 after SAH

Study Arms (2)

Intraventricular tPA

ACTIVE COMPARATOR

Tissue Plasminogen Activator (tPA) Dose: 1 mg Q8 hr x 12 doses, or until blood is cleared from the ventricles and cisterns Adminstration: Intraventricular; via previously placed external ventricular drain

Drug: Tissue Plasminogen Activator

Placebo

PLACEBO COMPARATOR

Placebo Dose 1 mL sterile saline

Drug: Tissue Plasminogen Activator

Interventions

Tissue Plasminogen Activator DRUG

Dose: 1mg Q8 x 12 doses, or until clearance of blood from ventricles and cisterns Administration: intraventricular administration (through external ventricular drain)

Also known as: Activase, Alteplase

Intraventricular tPA; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years old.
• SAH due to aneurysm, as determined by CT angiogram or cerebral angiogram.
• Modified Fisher (mF) grade 3 or 4 SAH, defined as thick cisternal blood without (grade 3) or with (grade 4) intraventrciular blood.
• Ventriculostomy placement must occur prior to randomization.
• Informed consent obtained from the patient or patient's decision maker

You may not qualify if:

• Determination by treating physician(s) that no ventriculostomy is needed.
• Presence of intrinsic clotting disorders (e.g. due to hepatic failure, nephrotic syndrome, etc). Subjects whose pharmacologic anticoagulation is reversed, as determined by PT/INR, PTT within our institution's normal range, will be permitted to participate in this study.
• Presence of significant anemia, defined as hemoglobin \< 8 gm/dL.
• Patients who undergo endovascular techniques requiring post-operative dual anti-platelet therapy.
• Residual aneurysm sac filling (Raymond class III occlusion).
• Aneurysm or vessel perforation during the endovascular procedure.
• Presence of craniectomy.
• Significant neurologic disability prior to the onset of SAH.
• Determination that administration of tPA/placebo cannot be initiated within 72 hours of symptom onset.
• Presence of untreated intracranial aneurysms larger than 3mm on CT angiography or cerebral angiogram.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial; Intracranial Aneurysm; Hydrocephalus

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Aneurysm

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Stephan Munich, MD

  Rush University Medical Center, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

• Roham Moftakhar, MD

  Rush University Medical Center, Department of Neurosurgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgery Resident

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 14, 2013
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 11, 2015

Record last verified: 2015-11

Locations

US (1)