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Dose-effect Relationship of Rt-PA on ICH Evacuation

Primary Purpose

Hypertensive Intracerebral Hemorrhage

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
YL-1 type of intracranial hematoma puncture needle
rt-PA
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Intracerebral Hemorrhage focused on measuring Intracerebral Hemorrhage, minimally invasive surgery, recombinant tissue plasminogen activator, Dose-effect Relationship

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80.
  • GCS < 14 or a NIHSS > or equal to 6.
  • Spontaneous supratentorial ICH ≥ 20 mL diagnosed using radiographic imaging (CT, CTA, etc.)
  • Symptoms less than 24 hours prior to diagnostic CT(dCT) scan (an unknown time of symptom onset is exclusionary).
  • Six-hour clot size equal to the most previous clot size (within 5 mL) as determined by additional CT scans at least 6 hours apart using the ABC/2 method.
  • Intention to initiate surgery between 12 and 72 hours after after diagnostic CT. First dose can be given within 76 hours after dCT (delays for post surgical stabilization of catheter bleeding).
  • SBP < 180 mmHg sustained for 6 hours recorded closest to time of randomization.
  • Historical Rankin score of 0 or 1.
  • Negative pregnancy test.

Exclusion Criteria:

  • Infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy).
  • Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4.
  • Intraventricular hemorrhage requiring treatment with extraventricular drainage (obstruction of third and fourth ventricles).
  • Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease diagnosed with radiographic imaging.
  • Any irreversible coagulopathy or known clotting disorder. or having the experience of the use of anticoagulant drug.
  • Platelet count < 100,000, INR > 1.7, or an elevated prothrombin time (PT) or activated partial thromboplastin time (aPTT).
  • Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization.
  • Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
  • Historical Rankin score greater than or equal to 2.

Sites / Locations

  • Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

0.3 mg

0.5 mg

1.0 mg

Arm Description

Subjects randomized to the 0.3 mg arm will undergo minimally invasive surgery with YL-1 type of intracranial hematoma puncture needle, followed by up to 4 doses of 0.3 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

Subjects randomized to the 0.5 mg arm will undergo minimally invasive surgery with YL-1 type of intracranial hematoma puncture needle,followed by up to 4 doses of 0.5 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

Subjects randomized to the 1.0 mg arm will undergo minimally invasive surgery with YL-1 type of intracranial hematoma puncture needle,followed by up to 4 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

Outcomes

Primary Outcome Measures

rate of clot size removal

Secondary Outcome Measures

Mortality
Procedure related mortality
Incidence of intracranial infection
Rate of rebleeding
Glasgow outcome scale gos
Glasgow outcome scale gos
Rankin stroke impact scale
Rankin stroke impact scale

Full Information

First Posted
May 17, 2015
Last Updated
June 11, 2015
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02472574
Brief Title
Dose-effect Relationship of Rt-PA on ICH Evacuation
Official Title
Phase 2 Study of Rt-PA Dose-effect Relationship on ICH Evacuation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to determine the optimal dose of rt-PA in the treatment of intracerebral hemorrhage (ICH) using a combination of minimally invasive surgery and clot lysis with rt-PA。
Detailed Description
The minimally invasive surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) is one of the best choices in the treatment of a large-scale deep supratentorial intracerebral hematoma. It uses hardware access technology, in a relatively short time to enter the hematoma center with favourable accuracy and safety. The dose of rt-PA range from 0.3 mg to 4.0 mg in different research。We propose to determine the optimal dose of rt-PA with three dose control groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Intracerebral Hemorrhage
Keywords
Intracerebral Hemorrhage, minimally invasive surgery, recombinant tissue plasminogen activator, Dose-effect Relationship

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.3 mg
Arm Type
Experimental
Arm Description
Subjects randomized to the 0.3 mg arm will undergo minimally invasive surgery with YL-1 type of intracranial hematoma puncture needle, followed by up to 4 doses of 0.3 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.
Arm Title
0.5 mg
Arm Type
Experimental
Arm Description
Subjects randomized to the 0.5 mg arm will undergo minimally invasive surgery with YL-1 type of intracranial hematoma puncture needle,followed by up to 4 doses of 0.5 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.
Arm Title
1.0 mg
Arm Type
Experimental
Arm Description
Subjects randomized to the 1.0 mg arm will undergo minimally invasive surgery with YL-1 type of intracranial hematoma puncture needle,followed by up to 4 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.
Intervention Type
Device
Intervention Name(s)
YL-1 type of intracranial hematoma puncture needle
Other Intervention Name(s)
aspiration drainage
Intervention Description
YL-1 type of intracranial hematoma puncture needle(Pat. NO.is ZL:93244252•8) was originated by Beijing WanTeFu Medical Apparatus Co.Ltd in 1997. With integration of needle and bur drill it is designed as hard tunnel.By the technique of skull self-holding, the puncture needle can being fixed in the target of haematoma for several days.This technique is convenient, simple and safe. To position haematoma's location, drills 3 millimeter holes in the localization point of puncture, then insert the drainage tube to inhale hematoma, gives the filament resolver interrupted for liquefication drainage afterward.
Intervention Type
Drug
Intervention Name(s)
rt-PA
Other Intervention Name(s)
recombinant tissue plasminogen activator
Intervention Description
Up to 4 doses of 0.3~1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
Primary Outcome Measure Information:
Title
rate of clot size removal
Time Frame
baseline to 24 hours(±12) post the last dose of rt-PA
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
30 days
Title
Procedure related mortality
Time Frame
30 days
Title
Incidence of intracranial infection
Time Frame
30 days
Title
Rate of rebleeding
Time Frame
30 days
Title
Glasgow outcome scale gos
Time Frame
90 days
Title
Glasgow outcome scale gos
Time Frame
180 days
Title
Rankin stroke impact scale
Time Frame
90 days
Title
Rankin stroke impact scale
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80. GCS < 14 or a NIHSS > or equal to 6. Spontaneous supratentorial ICH ≥ 20 mL diagnosed using radiographic imaging (CT, CTA, etc.) Symptoms less than 24 hours prior to diagnostic CT(dCT) scan (an unknown time of symptom onset is exclusionary). Six-hour clot size equal to the most previous clot size (within 5 mL) as determined by additional CT scans at least 6 hours apart using the ABC/2 method. Intention to initiate surgery between 12 and 72 hours after after diagnostic CT. First dose can be given within 76 hours after dCT (delays for post surgical stabilization of catheter bleeding). SBP < 180 mmHg sustained for 6 hours recorded closest to time of randomization. Historical Rankin score of 0 or 1. Negative pregnancy test. Exclusion Criteria: Infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy). Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4. Intraventricular hemorrhage requiring treatment with extraventricular drainage (obstruction of third and fourth ventricles). Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease diagnosed with radiographic imaging. Any irreversible coagulopathy or known clotting disorder. or having the experience of the use of anticoagulant drug. Platelet count < 100,000, INR > 1.7, or an elevated prothrombin time (PT) or activated partial thromboplastin time (aPTT). Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization. Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease. Historical Rankin score greater than or equal to 2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhu Suiqiang, doctor
Organizational Affiliation
Hubei Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19066101
Citation
Morgan T, Zuccarello M, Narayan R, Keyl P, Lane K, Hanley D. Preliminary findings of the minimally-invasive surgery plus rtPA for intracerebral hemorrhage evacuation (MISTIE) clinical trial. Acta Neurochir Suppl. 2008;105:147-51. doi: 10.1007/978-3-211-09469-3_30.
Results Reference
background
PubMed Identifier
23391763
Citation
Mould WA, Carhuapoma JR, Muschelli J, Lane K, Morgan TC, McBee NA, Bistran-Hall AJ, Ullman NL, Vespa P, Martin NA, Awad I, Zuccarello M, Hanley DF; MISTIE Investigators. Minimally invasive surgery plus recombinant tissue-type plasminogen activator for intracerebral hemorrhage evacuation decreases perihematomal edema. Stroke. 2013 Mar;44(3):627-34. doi: 10.1161/STROKEAHA.111.000411. Epub 2013 Feb 7.
Results Reference
background
PubMed Identifier
24710926
Citation
Lian LF, Xu F, Tang ZP, Xue Z, Liang QM, Hu Q, Zhu WH, Kang HC, Liu XY, Wang FR, Zhu SQ. Intraclot recombinant tissue-type plasminogen activator reduces perihematomal edema and mortality in patients with spontaneous intracerebral hemorrhage. J Huazhong Univ Sci Technolog Med Sci. 2014 Apr;34(2):165-171. doi: 10.1007/s11596-014-1252-x. Epub 2014 Apr 8.
Results Reference
background
PubMed Identifier
22274965
Citation
Tang ZP, Shi YH, Yin XP, Xu JZ, Zhang SM, Wang W. Modifying the details of aspiration operation may contribute to the improvement of prognosis of patients with ICH. Turk Neurosurg. 2012;22(1):13-20. doi: 10.5137/1019-5149.JTN.4219-11.0.
Results Reference
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Dose-effect Relationship of Rt-PA on ICH Evacuation

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