Trial · NCT00810888
The Spot Sign for Predicting and Treating ICH Growth Study
NCT00810888, Phase 2, Completed, University of Cincinnati; results first posted 2018-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Spot Sign for Predicting and Treating ICH Growth Study. Trials, record NCT00810888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00810888
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Spot Sign for Predicting and Treating ICH Growth Study
- NCT number
- NCT00810888
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- University of Cincinnati
- Conditions
- Intracerebral Hemorrhage
- Interventions
- recombinant activated factor VII, placebo
- First posted
- 2008-12-18
- Last updated
- 2018-03-16
- Results first posted
- 2018-01-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Study Subjects With Life-threatening Thromboembolic Complications | through day 4 after completion of study drug administration | Thromboembolic complications are defined as development of (1) acute myocardial ischemia; or (2) acute cerebral ischemia; or (3) acute pulmonary embolism |
| Primary | Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours. | From baseline to 24 hours | Comparison of only the subjects with a positive spot sign with respect to a categorical measure of hematoma growth from baseline to 24 hours. the outcome of interest is the percent of subjects with hematoma growth \> 33% or \> 6 cc increase in volume, from baseline to 24 hours. |
| Primary | The Sensitivity of the Spot Sign for Predicting Hematoma Growth | Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours. | The outcome measure is hematoma growth. Groups 2 and 3 only will be compared as Group 1 had administration of study drug which was hypothesized to reduce hematoma growth. Sensitivity was estimated. Sensitivity or true positive rate is defined as, the number of strokes correctly identified as spot positive according to the "gold standard" / the total number of strokes identified as spot positive |
| Primary | The Specificity of the Spot Sign for Predicting Hematoma Growth | Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours. | The outcome measure is hematoma growth. Groups 2 and 3 only will be compared as group 1 had administration of study drug which was hypothesized to reduce hematoma growth. Specificity was estimated. Specificity or true negative rate is defined as, the number of non-spot positive (spot negative) strokes according to the "gold standard" / the total number of strokes identified as not spot positive. |
| Secondary | Number of Participants With Other Potentially Study Drug Related Thromboembolic Complications Such as Deep Venous Thrombosis (DVT) and Elevations in Troponin Not Associated With ECG Changes | through day 4 after completion of study drug | Evidence of a deep venous thrombosis or an elevation of troponin within 4 days of completion of study drug administration that are not associated with ECG changes that could be related to the study drug |
| Secondary | Number of Spot Positive Subjects With 90-day Outcome of Modified Rankin Scale Score >= 5 | 90 days (+/- 7 days) from time of study enrollment | The modified Rankin Scale (0 is best, 5 is worst - non dead, 6 is dead) was used to define a bad outcome; categorized as a score \>=5 versus \<5. As the aim of the study was to examine the effect of rFIV!!a only the randomized groups, 1 and 2, defined as spot positive by CTA were compared. |
| Secondary | Number of Participants With Agreement Between the Clinical Site Radiologists and the Study Radiologist With Respect to Identification of a Positive Spot Sign or the Absence of Positive Spot Sign on CTA | Baseline head CT scan within 5 hours, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours. | The CTA was originally interpreted by the site radiologist so that subjects could be identified as having a positive spot sign for eligibility for randomization. The positive spot sign is indicative that there is potential for further hemorrhagic growth and these subjects were thus eligible to be randomized to receive investigational drug or placebo. The CTA scans were subsequently assessed by the study radiologist and compared for agreement. |
| Secondary | Percent Change in Total Hemorrhage Volume (Intracerebral Hemorrhage (ICH) Plus Intraventricular Hemorrhage (IVH)). | 24 hours (+/- 3 hours) from baseline CT scan | Percent change in total volume (intracerebral hemorrhage (ICH) plus intraventricular hemorrhage (IVH)) from baseline CT to 24 hour CT. Percent change is expressed as difference between 24 hour total volume and baseline total volume divided by baseline total volume, expressed as a percentage. In order to examine the effect of rFIVIIa, the randomized groups, Group 1 and Group 2 only were statistically compared. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Study Subjects With Life-threatening Thromboembolic Complications | through day 4 after completion of study drug administration | The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours. | From baseline to 24 hours | The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Sensitivity of the Spot Sign for Predicting Hematoma Growth | Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours. | The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group 2 and Group 3. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Specificity of the Spot Sign for Predicting Hematoma Growth | Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours. | The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group 2 and Group 3. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Other Potentially Study Drug Related Thromboembolic Complications Such as Deep Venous Thrombosis (DVT) and Elevations in Troponin Not Associated With ECG Changes | through day 4 after completion of study drug | The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Spot Positive Subjects With 90-day Outcome of Modified Rankin Scale Score >= 5 | 90 days (+/- 7 days) from time of study enrollment | The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Agreement Between the Clinical Site Radiologists and the Study Radiologist With Respect to Identification of a Positive Spot Sign or the Absence of Positive Spot Sign on CTA | Baseline head CT scan within 5 hours, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours. | The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Overall agreement was assessed but reported by group below. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in Total Hemorrhage Volume (Intracerebral Hemorrhage (ICH) Plus Intraventricular Hemorrhage (IVH)). | 24 hours (+/- 3 hours) from baseline CT scan | The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2. | Percent change from baseline to 24 hours | MEDIAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Study Subjects With Life-threatening Thromboembolic Complications | Group 1 - Randomized to Study Drug | 1 | Participants | ||
| Number of Study Subjects With Life-threatening Thromboembolic Complications | Group 2 - Randomized to Placebo | 0 | Participants | ||
| Number of Study Subjects With Life-threatening Thromboembolic Complications | Group 3 - Observation Only Arm | 0 | Participants | ||
| Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours. | Group 1 - Randomized to Study Drug | 4 | Participants | ||
| Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours. | Group 2 - Randomized to Placebo | 5 | Participants | ||
| Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours. | Group 3 - Observation Only Arm | 8 | Participants | ||
| The Sensitivity of the Spot Sign for Predicting Hematoma Growth | Group 1 - Randomized to Study Drug | 4 | Participants | ||
| The Sensitivity of the Spot Sign for Predicting Hematoma Growth | Group 2 - Randomized to Placebo | 5 | Participants | ||
| The Sensitivity of the Spot Sign for Predicting Hematoma Growth | Group 3 - Observation Only Arm | 8 | Participants | ||
| The Specificity of the Spot Sign for Predicting Hematoma Growth | Group 1 - Randomized to Study Drug | 4 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 - Randomized to Study Drug | 10 | |
| Overall Study | STARTED | Group 2 - Randomized to Placebo | 9 | |
| Overall Study | STARTED | Group 3 - Observation Only Arm | 73 | |
| Overall Study | COMPLETED | Group 1 - Randomized to Study Drug | 10 | |
| Overall Study | COMPLETED | Group 2 - Randomized to Placebo | 9 | |
| Overall Study | COMPLETED | Group 3 - Observation Only Arm | 73 | |
| Overall Study | NOT COMPLETED | Group 1 - Randomized to Study Drug | 0 | |
| Overall Study | NOT COMPLETED | Group 2 - Randomized to Placebo | 0 | |
| Overall Study | NOT COMPLETED | Group 3 - Observation Only Arm | 0 |
Source ClinicalTrials.gov
Adverse events306
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 | Leukocytosis | Blood and lymphatic system disorders | Group 1 - Randomized to Study Drug | 2 | 10 | 2 |
| other | Leukocytosis | Blood and lymphatic system disorders | Group 2 - Randomized to Placebo | 1 | 9 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Group 3 - Observation Only Arm | 2 | 73 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Group 1 - Randomized to Study Drug | 1 | 10 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Group 2 - Randomized to Placebo | 0 | 9 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Group 3 - Observation Only Arm | 0 | 73 | 0 |
| other | Bradycardia | Cardiac disorders | Group 1 - Randomized to Study Drug | 2 | 10 | 2 |
| other | Bradycardia | Cardiac disorders | Group 2 - Randomized to Placebo | 0 | 9 | 0 |
| other | Bradycardia | Cardiac disorders | Group 3 - Observation Only Arm | 1 | 73 | 1 |
| other | Congestive heart failure | Cardiac disorders | Group 1 - Randomized to Study Drug | 1 | 10 | 1 |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 - Randomized to Study Drug | 2 | 10 |
| Total, all-cause mortality | Group 2 - Randomized to Placebo | 0 | 9 |
| Total, all-cause mortality | Group 3 - Observation Only Arm | 4 | 73 |
| Total, other adverse events | Group 1 - Randomized to Study Drug | 9 | 10 |
| Total, other adverse events | Group 2 - Randomized to Placebo | 8 | 9 |
| Total, other adverse events | Group 3 - Observation Only Arm | 65 | 73 |
| Total, serious adverse events | Group 1 - Randomized to Study Drug | 4 | 10 |
| Total, serious adverse events | Group 2 - Randomized to Placebo | 4 | 9 |
| Total, serious adverse events | Group 3 - Observation Only Arm | 16 | 73 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31424491 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| P50NS044283 | Recanalization Therapies and Markers of Stroke Outcome | BRODERICK, JOSEPH PAUL | UNIVERSITY OF CINCINNATI | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2002 to 2012 |
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.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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