Intraventricular Tissue Plasminogen Activator (tPA) in the Management of Aneurysmal Subarachnoid Hemorrhage

NCT01098890 | Unknown Phase 2

• 1 other identifier: 22461
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is to evaluate the acceleration the clearance of intraventricular blood (IVH) and subarachnoid hemorrhage (SAH) following ruptured intracranial aneurysms, thereby ameliorating complications, such as cerebral vasospasm, hydrocephalus and intracranial hypertension. The primary objectives are:

1. 1.Estimate the rate and variance of hematoma clearance following aneurysmal SAH, thereby facilitating sample size determination for a subsequent larger study;
2. 2.Assess the feasibility of a randomized controlled trial of intraventricular tissue plasminogen activator (TPA) among patients with SAH (enrollment rate, ability to blind investigators, protocol compliance);
3. 3.Confirm the safety of intraventricular TPA.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Intraventricular Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Determine rate and variance of ventricular and cisternal clot clearance (with and without TPA).

  In order to plan the sample size for a future "proof-of-concept" trial, we need to better define the primary endpoint (the rate of ventricular and cisternal clot clearance, as well as the degree of variance in this rate, both with and without TPA).

  8 Days post bleed

Secondary Outcomes (2)

• Confirm the safety of intraventricular TPA.

  6 months

• Assess feasibility of a future multi-center trial

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo will be administered every 12 hours for a total five doses. Patients will be followed for a total of 6 months.

Drug: Placebo

tPA (tissue plaminogen activator)

ACTIVE COMPARATOR

Intraventricular TPA will be administered every 12 hours for a total five doses. Patients will be followed for a total of 6 months.

Drug: Tissue Plasminogen Activator

Interventions

Tissue Plasminogen Activator DRUG

2mg tPA will be given every twelve hours for a maximum of 5 doses

Also known as: Cathflo

tPA (tissue plaminogen activator)

Placebo DRUG

Placebo will be administered every 12 hours for a maximum of 5 doses.

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult patients (\> 18 years old) with a proven ruptured cerebral aneurysm
• Aneurysm has been / will be treated with coil embolization
• EVD has been / will be placed as part of routine care
• Modified Fisher score is 4 (cisternal blood \> 1 mm thick with concomitant IVH)
• Study drug can be administered within 72 hours of the time of SAH.

You may not qualify if:

• Concern expressed by endovascular neurosurgeon / interventional radiologist that aneurysm has only been incompletely treated / isolated by coil embolization.
• Patient requires craniotomy and clipping of the culprit aneurysm.
• CT scan performed post-EVD insertion OR post-coiling shows increase in amount of intracranial blood.
• Uncorrected coagulation disturbance (INR \> 1.5, PTT \> 45); correction is permitted (if coagulation disturbance develops during the study, subsequent doses of TPA should simply be withheld until coagulation can be corrected).
• Uncorrected thrombocytopenia (platelets \< 50,000); correction with platelet transfusions is permitted.
• Involvement in another clinical trial
• Uncontrolled active internal hemorrhage
• Known allergy to study drug
• Patient is pregnant
• Any other condition the investigator believes would place the subject at risk if included in the study.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage

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

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

• Andreas Kramer, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 5, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: April 1, 2012
• Last Updated: November 11, 2010

Record last verified: 2010-04

Locations

CA (1)