Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage

NCT ID: NCT01064011

Last Updated: 2011-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-01-31

Brief Summary

Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in the United States. In the emergent setting, patients with obstructive hydrocephalus are routinely treated with placement of an external ventricular drain. This study will compare the effect of external ventricular drainage plus intraventricular thrombolysis versus external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients with hydrocephalus from intraventricular hemorrhage.

Conditions

Intraventricular Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

External Ventricular drainage, Intraventricular Thrombolysis

Group Type: OTHER

Rt-PA thrombolysis

Intervention Type: PROCEDURE

patients will be administered a total of six doses of rt-PA (each 1 mg/ml) through the external ventricular drain every eight hours.

External Ventricular Drainage and Endoscopic Evacuation

Group Type: OTHER

endoscopic hematoma evacuation

Intervention Type: PROCEDURE

In the operating room under general anesthesia, the external ventricular drain will be removed and the burr hole enlarged to allow for entry of the endoscope. The neuroscope will be introduced through the burr hole down the prior external ventricular drain tract into the ipsilateral ventricle. utilizing a standard technique combining gentle aspiration, continuous irrigation, and grasping forceps,the intraventricular hematoma will be evacuated. After the evacuation the endoscope will be removed and an external ventricular drain will be reattached to a closed system and permitted to drain post-operatively.

Interventions

Rt-PA thrombolysis

patients will be administered a total of six doses of rt-PA (each 1 mg/ml) through the external ventricular drain every eight hours.

Intervention Type: PROCEDURE

endoscopic hematoma evacuation

In the operating room under general anesthesia, the external ventricular drain will be removed and the burr hole enlarged to allow for entry of the endoscope. The neuroscope will be introduced through the burr hole down the prior external ventricular drain tract into the ipsilateral ventricle. utilizing a standard technique combining gentle aspiration, continuous irrigation, and grasping forceps,the intraventricular hematoma will be evacuated. After the evacuation the endoscope will be removed and an external ventricular drain will be reattached to a closed system and permitted to drain post-operatively.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 18-75
• Radiographic evidence of intraventricular hemorrhage with hydrocephalus
• Admission Glasgow Coma Scale ≥ 5 (motor score ≥ 2)
• Placement of an external ventricular drain with an opening pressure >20 mm Hg

Exclusion Criteria

• Intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous malformation, or tumor
• Coagulopathy (Platelet count <100,000, International normalized ratio >1.5. Reversal of warfarin is permitted.)
• Age <18 or >75
• Pregnancy (positive pregnancy test)
• Clotting disorders
• Medical contraindications to administration of general anesthesia as determined by the attending anesthesiologist
• Medical contraindications to surgery as determined by the attending neurosurgeon
• Contraindication to recombinant tissue plasminogen activator administration:

• Evidence of enlargening intracranial hemorrhage as evidenced by an increase in intracranial hemorrhage volume (>5 ml) on CT obtained after EVD placement
• Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
• Superficial or surface bleeding, observed at vascular puncture and access sites (e.g. venous cutdowns, arterial punctures) or site of recent surgical intervention
• Evidence of cerebrospinal infection by Gram stain or culture
• Advanced directive indicating Do Not Resuscitate or Do Not Intubate status

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Albany Medical College

Locations

Albany Medical Center

Albany, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yu-Hung Kuo, MD

Role: CONTACT

kuoy@mail.amc.edu

518 262-5088

Tyler Kenning, MD

Role: CONTACT

kennint@mail.amc.edu

518 262-5088

Facility Contacts

Yu-Hung Kuo, MD

Role: primary

kuo@mail.amc.edu

518-262-5088

Tyler Kenning, MD

Role: backup

kennint@mail.amc.edu

518 262-5088

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id