Trial · NCT00224770
Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation
NCT00224770, Phase 2, Completed, Daniel Hanley; results first posted 2015-06-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation. Trials, record NCT00224770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00224770
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation
- NCT number
- NCT00224770
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 141 participants, actual
- Lead sponsor
- Daniel Hanley
- Conditions
- Intracerebral Hemorrhage
- Interventions
- MIS+Cathflo Activase (drug), Intraoperative stereotactic CT-Guided Endoscopic Surgery
- First posted
- 2005-09-23
- Last updated
- 2015-06-18
- Results first posted
- 2015-06-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Outcome Number 1: Rate of Mortality | 30 days from randomization | Percentage of participants who died during the first 30 days after randomization. |
| Primary | Safety Outcome Number 2: Rate of Procedure-related Mortality | 7 days from randomization | Percentage of participants who died during the first 7 days after randomization. |
| Primary | Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis | 30 days from randomization | Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization. |
| Primary | Safety Outcome Number 4: Rate of Symptomatic Rebleeding | 72 hours post last dose | The difference in the rate of symptomatic rebleeding 72 hours post last dose. |
| Primary | Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180 | 180 days from randomization | Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead |
| Secondary | Ordinal Modified Rankin Scale (mRS) at Day 180 | 180 days from randomization | Ordinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead. |
| Secondary | Ordinal Modified Rankin Scale (mRS) at Day 365 | 365 days from randomization | Ordinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead. |
| Secondary | Clot Size Reduction by End of Treatment | Time from randomization until end of treatment, up to 10 days | The percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan. |
| Secondary | Post-operative Clot Size Reduction | Time from post-operation until end of treatment, up to 10 days | The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety Outcome Number 1: Rate of Mortality | 30 days from randomization | percentage of participants | NUMBER | |
| PRIMARY | Safety Outcome Number 2: Rate of Procedure-related Mortality | 7 days from randomization | percentage of participants | NUMBER | |
| PRIMARY | Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis | 30 days from randomization | percentage of participants | NUMBER | |
| PRIMARY | Safety Outcome Number 4: Rate of Symptomatic Rebleeding | 72 hours post last dose | percentage of participants | NUMBER | |
| SECONDARY | Ordinal Modified Rankin Scale (mRS) at Day 180 | 180 days from randomization | units on a scale | MEDIAN | |
| SECONDARY | Ordinal Modified Rankin Scale (mRS) at Day 365 | 365 days from randomization | units on a scale | MEDIAN | |
| SECONDARY | Clot Size Reduction by End of Treatment | Time from randomization until end of treatment, up to 10 days | percentage of blood clot resolved | MEDIAN | |
| SECONDARY | Post-operative Clot Size Reduction | Time from post-operation until end of treatment, up to 10 days | Analysis population only includes surgical patients. | percentage of blood clot resolved | MEDIAN |
| PRIMARY | Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180 | 180 days from randomization | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Outcome Number 1: Rate of Mortality | Medical Management | 9.5 | 90% Confidence Interval 3.3 to 20.5 | percentage of participants | |
| Safety Outcome Number 1: Rate of Mortality | MISTIE Surgical Management | 14.8 | 90% Confidence Interval 7.6 to 25.1 | percentage of participants | |
| Safety Outcome Number 1: Rate of Mortality | ICES Surgical Management | 7.1 | 90% Confidence Interval 0.4 to 29.7 | percentage of participants | |
| Safety Outcome Number 2: Rate of Procedure-related Mortality | Medical Management | 0 | 90% Confidence Interval 0 to 6.9 | percentage of participants | |
| Safety Outcome Number 2: Rate of Procedure-related Mortality | MISTIE Surgical Management | 5.6 | 90% Confidence Interval 1.5 to 13.7 | percentage of participants | |
| Safety Outcome Number 2: Rate of Procedure-related Mortality | ICES Surgical Management | 0 | 90% Confidence Interval 0 to 19.3 | percentage of participants | |
| Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis | Medical Management | 2.4 | 90% Confidence Interval 0.1 to 10.8 | percentage of participants | |
| Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis | MISTIE Surgical Management | 0 | 90% Confidence Interval 0 to 5.4 | percentage of participants | |
| Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis | ICES Surgical Management | 0 | 90% Confidence Interval 0 to 19.3 | percentage of participants | |
| Safety Outcome Number 4: Rate of Symptomatic Rebleeding | Medical Management | 2.4 | 90% Confidence Interval 0.1 to 10.8 | percentage of participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Medical Management | 42 | |
| Overall Study | STARTED | MISTIE Surgical Management | 54 | |
| Overall Study | STARTED | ICES Surgical Management | 14 | |
| Overall Study | COMPLETED | Medical Management | 38 | |
| Overall Study | COMPLETED | MISTIE Surgical Management | 52 | |
| Overall Study | COMPLETED | ICES Surgical Management | 14 | |
| Overall Study | NOT COMPLETED | Medical Management | 4 | |
| Overall Study | NOT COMPLETED | MISTIE Surgical Management | 2 | |
| Overall Study | NOT COMPLETED | ICES Surgical Management | 0 |
Source ClinicalTrials.gov
Adverse events276
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acute renal failure | Renal and urinary disorders | Medical Management | 1 | 42 | 1 |
| other | Acute renal failure | Renal and urinary disorders | MISTIE Surgical Management | 3 | 54 | 3 |
| other | Acute renal failure | Renal and urinary disorders | ICES Surgical Management | 0 | 14 | 0 |
| other | Aspiration | Respiratory, thoracic and mediastinal disorders | Medical Management | 5 | 42 | 5 |
| other | Aspiration | Respiratory, thoracic and mediastinal disorders | MISTIE Surgical Management | 1 | 54 | 1 |
| other | Aspiration | Respiratory, thoracic and mediastinal disorders | ICES Surgical Management | 0 | 14 | 0 |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | Medical Management | 1 | 42 | 1 |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | MISTIE Surgical Management | 3 | 54 | 3 |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | ICES Surgical Management | 0 | 14 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Medical Management | 2 | 42 | 2 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medical Management | ||
| Total, all-cause mortality | MISTIE Surgical Management | ||
| Total, all-cause mortality | ICES Surgical Management | ||
| Total, other adverse events | Medical Management | 24 | 42 |
| Total, other adverse events | MISTIE Surgical Management | 41 | 54 |
| Total, other adverse events | ICES Surgical Management | 8 | 14 |
| Total, serious adverse events | Medical Management | 23 | 42 |
| Total, serious adverse events | MISTIE Surgical Management | 28 | 54 |
| Total, serious adverse events | ICES Surgical Management | 6 | 14 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS046309 | ICH Removal: Minimally Invasive Surgery + rt-PA | HANLEY, DANIEL F | JOHNS HOPKINS UNIVERSITY | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2005 to 2011 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00224770
GET https://conductscience.org/api/trials/v1/NCT00224770/results?page=2