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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

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

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

Rankin stroke impact scale

Full Information

NCT ID

NCT02472574

First Posted

May 17, 2015

Last Updated

June 11, 2015

Sponsor

Tongji Hospital

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

Arm Title

0.5 mg

Arm Type

Experimental

Arm Description

Arm Title

1.0 mg

Arm Type

Experimental

Arm Description

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

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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