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Intracerebral HemorrhagePhase 3MISTIE-IIINCT01827046

Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III

A Phase 3 study testing rt-PA in people with Intracerebral Hemorrhage, run by Johns Hopkins University at 84 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
rt-PA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
499 participants
Where
84 sitesin 9 countries
Study dates
30 Dec 2013to Sep 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging (computerized tomography (CT), computerized tomography angiography (CTA), etc.), with a Glasgow Coma Scale (GCS) ≤ 14 or a NIHSS ≥ 6.
  • Stability CT scan done at least 6 hours after diagnostic CT showing clot stability (growth < 5 mL as measured by ABC/2 method).
  • Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of onset is exclusionary).
  • Ability to randomize between 12 and 72 hours after dCT.
  • Systolic Blood Pressure (SBP) < 180 mmHg sustained for six hours recorded closest to the time of randomization.
  • Historical Rankin score of 0 or 1.
  • Age ≥ 18 and older.

Who cannot join

  • Infratentorial hemorrhage.
  • Intraventricular hemorrhage (IVH) requiring treatment for IVH-related (casting) mass effect or shift due to trapped ventricle. External ventricular drain (EVD) to treat intracranial pressure (ICP) is allowed.
  • Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions. Note: Patients with a posterior fossa ICH or cerebellar hematomas are ineligible.
  • Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4.
  • Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (< 1 year) hemorrhage diagnosed with radiographic imaging.
  • Patients with unstable mass or evolving intracranial compartment syndrome.
Show all 25Show fewer
  • Platelet count < 100,000; international normalized ratio (INR) > 1.4.
  • Any irreversible coagulopathy or known clotting disorder.
  • Inability to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as but not limited to NovoSeven, Fresh Frozen Plasma (FFP), and/or vitamin K).
  • Subjects requiring long-term anti-coagulation are excluded. Reversal of anti-coagulation is permitted for medically stable patients who can realistically tolerate the short term risk of reversal. Patient must not require Coumadin (anticoagulation) during the first 30 days, and normalized coagulation parameters must be demonstrated, monitored closely and maintained during the period of brain instrumentation.
  • Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
  • Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
  • Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures, etc.) or site of recent surgical intervention.
  • Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization.
  • Allergy/sensitivity to rt-PA.
  • Prior enrollment in the study.
  • Participation in a concurrent interventional medical investigation or clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving an intervention are eligible.
  • Not expected to survive to the day 365 visit due to co-morbidities and/or are do not resuscitate (DNR)/ do not intubate (DNI) status prior to randomization.
  • Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
  • Patients with a mechanical heart valve. Presence of bio-prosthetic valve(s) is permitted.
  • Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • In the investigator's opinion, the patient is unstable and would benefit from a specific intervention rather than supportive care plus or minus MIS+rt-PA removal of the ICH.
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Trial locations and contacts

84 sites in 9 countries.

84 sites in 9 countries

United States56 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • University of Michigan

    Ann Arbor, Michigan, 48190

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of Buffalo

    Buffalo, New York, 14203

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • University of Texas Southwestern at Dallas

    Dallas, Texas, 75390

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Henry Ford Heath System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Northshore University Health System, Evanston

    Evanston, Illinois, 60201

  • Fairfax INOVA Hospital

    Falls Church, Virginia, 22042

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • University of Texas, Houston

    Houston, Texas, 77030

  • Mayo Clinic, Jacksonville

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Scripps Health

    La Jolla, California, 92037

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30046

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • North Shore Long Island Jewish Health System

    Manhasset, New York, 11030

  • Loyola University Chicago

    Maywood, Illinois, 60305

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Intermountain Neurosciences Institute

    Murray, Utah, 84107

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Rutgers - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Yale University

    New Haven, Connecticut, 06510

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Weill Cornell Medical College

    New York, New York, 10065

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Temple University School of Medicine

    Philadelphia, Pennsylvania, 19140

  • Banner Good Samaritan Hospital

    Phoenix, Arizona, 85006

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence Brain and Spine Institute

    Portland, Oregon, 97225

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of Texas at San Antonio

    San Antonio, Texas, 78229

  • University of California, San Diego

    San Diego, California, 92103

  • Washington University

    St Louis, Missouri, 63110

  • Stanford University

    Stanford, California, 94305

  • State University of New York, Upstate Medical University

    Syracuse, New York, 13210

  • Albert Einstein College of Medicine - Montefiore Medical Center

    The Bronx, New York, 10467

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain6 sites

  • Hospital Universitario Cruces

    Barakaldo, Biscay, 48903

  • Vall d'Hebron University Hospital

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Bellvitge

    Barcelona, 08907

  • Hospital Universitario Mutua de Terrassa

    Barcelona

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

Other trials in Spain

Germany4 sites

  • University of Bonn

    Bonn, 53127

  • University of Heidelberg

    Heidelberg, 69120

  • University of Mainz

    Mainz, D-55131

  • University of Munich

    Munich, 81925

Other trials in Germany

United Kingdom4 sites

  • South Glasgow University Hospital

    Glasgow, G51 4TF

  • Newcastle Royal Victoria Infirmary

    Newcastle upon Tyne

  • Salford Royal NHS Foundation Trust

    Salford, Manchester, M6 8HD

  • University of Southampton Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Australia3 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2015

  • Royal Adelaide Hospital

    North Adelaide, South Australia, 5006

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Canada3 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

  • McMaster University

    Hamilton, Ontario, L8L 2X2

  • Montreal Neurological Institute, McGill University

    Montreal, Quebec, H3A 2B4

Other trials in Canada

China3 sites

  • Bayi Brain Hospital, Beijing Military General Hospital

    Beijing, 100700

  • Southwest Hospital, Third Military Medical University

    Chongqing, 400038

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

Other trials in China

Hungary3 sites

  • University of Debrecen

    Debrecen, 4032

  • University of Pecs

    Pécs, Baranya, 7623

  • University of Szeged

    Szeged, 6720

Other trials in Hungary

Israel2 sites

  • Rabin Medical Center

    Petah Tikva

  • The Chaim Sheba Medical Center at Tel Hashomer

    Tel HaShomer, Ramat-Gan, 52621

Other trials in Israel

About this study

A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).

Read the detailed description

Primary Objectives:

Efficacy: Demonstrate that minimally invasive surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) for three days improves functional outcome by a 12% increase in the modified Rankin Scale (mRS) score 0-3 compared to medically treated subjects assessed at 365 days.

Secondary Objective:

Demonstrate that the end of treatment volume and percent of ICH reduction from MIS+rt-PA is related to improved functional outcome, as compared to medically treated subjects.

Safety:

Demonstrate that early use of MIS+rt-PA for three days is safe for the treatment of ICH relative to rates of mortality, rebleeding, and infection in the medically treated subject at 30 days.

Being tested
rt-PA
Keywords
intracerebral hemorrhage, ICH, brain hemorrhage, minimally invasive surgery, rt-PA
Medical subject headings
Cerebral Hemorrhage, Intracranial Hemorrhages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rt-PADrug

    Also called Activase, Alteplase, CathFlo

    Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.

Study groups in NCT01827046
Study groupRoleWhat they receive
MIS plus rt-PA managementExperimentalSubjects randomized to the Minimally Invasive Surgery (MIS) plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.
Receives: Drug: rt-PA
Medical managementNo interventionSubjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dichotomized, Adjudicated Modified Rankin Scale Score 0-3 vs. 4-6 at 365 Days Post Ictus (Adjusted)

    Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 365 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep). Ictus refers to symptom onset.

    The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death.

    Measured: Day 365

Secondary outcomes (11)

  1. Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 365 Days Post Ictus (Adjusted)

    Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 365 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).

    The eGOS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. Dichotomous variable coding is as follows: 1=codes 4-8, 0=codes 1-3.

    Measured: Day 365

  2. All Cause Mortality Longitudinally From Ictus to 365 Days (Adjusted)

    By group comparison of mortality from ictus to 365 days adjusted for baseline severity.

    Measured: Day 365

  3. Clot Removal (Amount of Residual Blood)

    Relationship between clot removal as an Area Under the Curve (AUC) clot-assessment that estimates the time-averaged clot volume from ictus to end of treatment (EOT i.e. 24 hours after last dose) as AUC clot exposure and functional outcome (proportion 0-3 Modified Rankin Scale (mRS)).

    Measured: 24 hours after last dose

  4. Patient Disposition: Home Days Over 365 Days Time From Ictus.

    By group comparison of cumulative days at home during the 365 days post ictus.

    Measured: During 365 days of follow-up

  5. Patient Disposition: Patient Location at 365 Days Post Ictus (i.e., Good vs. Bad Location) (Adjusted)

    Patient disposition: By group comparison of residential location at day 365 post ictus adjusted for baseline severity.

    Good locations refers to home and rehabilitation; and bad locations refers to acute care, long-term care and death.

    Measured: Day 365

  6. Dichotomized, Adjudicated, Cross-sectional Modified Rankin Scale (mRS) Score 0-3 vs. 4-6 180 Days Post Ictus (Adjusted)

    Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 180 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).

    The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death

    Measured: Day 180

  7. Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 180 Days Post Ictus (Adjusted)

    Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 180 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).

    The eGOS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. Dichotomous variable coding is as follows: 1=codes 4-8, 0=codes 1-3.

    Measured: Day 180

  8. Type and Intensity of ICU Management: ICU Days

    By group comparison of cumulative number of days in the Intensive Care Unit (ICU) in a hospital

    Measured: Up to 365 days

  9. Type and Intensity of ICU Management: Hospital Days

    By group comparison of total number of days in the hospital

    Measured: Up to 365 days

  10. EQ-VAS

    By group comparison of EQ-VAS at day 365 post ictus. The EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where subjects draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).

    Measured: Day 365

  11. EuroQol 5 Dimensional Scale (EQ-5D)

    By group comparison of EQ-5D at day 365 post ictus. The EuroQol 5 Dimensional Scale (Eq-5D) is a self-reported measure of health status. It is arranged to assess domains related to mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each domain, codes were 1=no problems, 2=some problems, 3=extreme problems, and 9=unknown. Having a problem in at least 1 domain was coded as 1 (originally represented by 2 or 3) and no problems as 0 (originally represented by 1) .

    Measured: Day 365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2013 (estimated)
  2. Study start30 Dec 2013
  3. Primary completionSep 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01827046
Sponsor's protocol ID
NA_00080619
Other IDs
U01NS080824, ICH02
Acronym
MISTIE-III
Status last verified
Sep 2019
First submitted
1 Apr 2013
Last updated
27 Sep 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Murray ON, Jenkins DA, Walborn N, Patel HC, Harston G, Cootes T, Klijn CJ, Ziai W, Hanley DF, Hammerbeck U, Parry-Jones AR. Corticospinal tract risk modifies motor recovery after minimally invasive surgery for intracerebral hemorrhage: a secondary analysis of MISTIE-III. medRxiv [Preprint]. 2026 Jun 11:2026.06.10.26354920. doi: 10.64898/2026.06.10.26354920.

    PubMed 42326800

  • Cooper DC, Abramson E, Ziai WC, Flaherty ML, Shah VA, Avadhani R, Ostapkovich N, Carhuapoma L, Awad I, Zuccarello M, Hanley D, Sansing LH. Intracerebral haemorrhage laterality and associations with mood and pain: a MISTIE III substudy. Stroke Vasc Neurol. 2025 Dec 23;10(6):734-742. doi: 10.1136/svn-2024-003755.

    PubMed 40250866

  • Sun P, Badihian S, Avadhani R, Walborn N, Yarava A, Alimoradi D, Awad I, Hanley D, Murthy S, Ziai W. Does stereotactic thrombolysis with alteplase for intracerebral haemorrhage alter intraventricular haematoma volume? A secondary analysis of the MISTIE-III trial. J Neurol Neurosurg Psychiatry. 2024 Sep 17;95(10):892-898. doi: 10.1136/jnnp-2023-333032.

    PubMed 38670789

  • Rivera-Lara L, Cho SM, Li Y, Ali H, McBee N, Awad IA, Avadhani R, Hanley DF, Gandhi D, Walborn N, Murthy SB, Ziai WC. Mechanistic Evaluation of Diffusion Weighted Hyperintense Lesions After Large Spontaneous Intracerebral Hemorrhage: A Subgroup Analysis of MISTIE III. Neurocrit Care. 2024 Jun;40(3):1140-1150. doi: 10.1007/s12028-023-01890-3. Epub 2023 Dec 1.

    PubMed 38040993

  • Bako AT, Potter T, Pan AP, Tannous J, Britz G, Ziai WC, Awad I, Hanley D, Vahidy FS. Minimally Invasive Surgery With Thrombolysis for Intracerebral Hemorrhage Evacuation: Bayesian Reanalysis of a Randomized Controlled Trial. Neurology. 2023 Oct 17;101(16):e1614-e1622. doi: 10.1212/WNL.0000000000207735. Epub 2023 Sep 8.

    PubMed 37684058

  • Magid-Bernstein JR, Li Y, Cho SM, Piran PJ, Roh DJ, Gupta A, Shoamanesh A, Merkler A, Zhang C, Avadhani R, Montano N, Iadecola C, Falcone GJ, Sheth KN, Qureshi AI, Rosand J, Goldstein J, Awad I, Hanley DF, Kamel H, Ziai WC, Murthy SB. Cerebral Microbleeds and Acute Hematoma Characteristics in the ATACH-2 and MISTIE III Trials. Neurology. 2022 Mar 8;98(10):e1013-e1020. doi: 10.1212/WNL.0000000000013247. Epub 2021 Dec 22.

    PubMed 34937780

  • Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.

    PubMed 30739747

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rt-PA in people with Intracerebral Hemorrhage, run by Johns Hopkins University at 84 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Spain, Germany, United Kingdom, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dichotomized, Adjudicated Modified Rankin Scale Score 0-3 vs. 4-6 at 365 Days Post Ictus (Adjusted) (time frame: Day 365). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01827046, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.

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