Intracerebral HemorrhageERICHNCT01202864
Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH)
An observational study of Intracerebral Hemorrhage, run by University of Cincinnati at 15 sites in United States.
Trial summary
The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH), among Caucasians, African Americans, and Hispanics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- How many people
- 6,000 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Aug 2010to 1 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Our purpose is to enroll 1000 cases of ICH among whites, 1000 cases of ICH among blacks, and 1000 cases of ICH among Hispanics. 3000 controls matched to cases by race/ethnicity, age (+/- 5 years), gender, and geographic location.
Who may be able to join
- All cases must meet the following eligibility criteria:
- Age 18 years or greater, fulfillment of the criteria for intracerebral hemorrhage
- Resident for at least 6 months within 50 miles of the recruiting center
- No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of the hemorrhage
- Ability of the patient or legal representative to provide informed consent
Who cannot join
- Malignancies leading to coagulopathy
- Hemorrhagic transformation of ischemic infarct
- Hemorrhage secondary to dural venous sinus thrombosis
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30303
University of Maryland
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Illinois
Chicago, Illinois, 60612
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
University of Texas Medical School at Houston
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
University of Miami - Biorepository
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
Columbia University
New York, New York, 10032
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
University of Arizona
Tucson, Arizona, 85724
Georgetown University
Washington D.C., District of Columbia, 20007
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH), among Caucasians, African Americans, and Hispanics.
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, ICH, Stroke, Cerebrovascular accident
- Medical subject headings
- Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | 3000 Cases | |
| Controls | 3000 Controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study start1 Aug 2010
- Primary completion31 Jul 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Columbia University, University of Maryland, Georgetown University, Wake Forest University, Emory University, University of Miami, University of Illinois Chicago, University of Texas, Southwestern Medical Center at Dallas, The University of Texas Health Science Center, Houston, The University of Texas Health Science Center at San Antonio, University of New Mexico, University of Arizona, University of Southern California, St. Luke's-Roosevelt Hospital Center, University of California, San Francisco, Duke University, University of Virginia, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Daniel Woo, University of Cincinnati
- Investigators
- Daniel Woo, MD, MS, Principal investigator, University of CincinnatiMatthew Flaherty, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202864
- Sponsor's protocol ID
- 1008059
- Other IDs
- R01NS069763-01
- Acronym
- ERICH
- Status last verified
- Aug 2017
- First submitted
- 14 Sep 2010
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. doi: 10.1161/01.str.27.9.1459.
PubMed 8784113Woo D, Sauerbeck LR, Kissela BM, Khoury JC, Szaflarski JP, Gebel J, Shukla R, Pancioli AM, Jauch EC, Menon AG, Deka R, Carrozzella JA, Moomaw CJ, Fontaine RN, Broderick JP. Genetic and environmental risk factors for intracerebral hemorrhage: preliminary results of a population-based study. Stroke. 2002 May;33(5):1190-5. doi: 10.1161/01.str.0000014774.88027.22.
PubMed 11988589Kissela B, Schneider A, Kleindorfer D, Khoury J, Miller R, Alwell K, Woo D, Szaflarski J, Gebel J, Moomaw C, Pancioli A, Jauch E, Shukla R, Broderick J. Stroke in a biracial population: the excess burden of stroke among blacks. Stroke. 2004 Feb;35(2):426-31. doi: 10.1161/01.STR.0000110982.74967.39.
PubMed 14757893Hardie K, Hankey GJ, Jamrozik K, Broadhurst RJ, Anderson C. Ten-year survival after first-ever stroke in the perth community stroke study. Stroke. 2003 Aug;34(8):1842-6. doi: 10.1161/01.STR.0000082382.42061.EE. Epub 2003 Jul 3.
PubMed 12843343Broderick JP, Phillips SJ, Whisnant JP, O'Fallon WM, Bergstralh EJ. Incidence rates of stroke in the eighties: the end of the decline in stroke? Stroke. 1989 May;20(5):577-82. doi: 10.1161/01.str.20.5.577.
PubMed 2718196Broderick JP, Brott T, Tomsick T, Miller R, Huster G. Intracerebral hemorrhage more than twice as common as subarachnoid hemorrhage. J Neurosurg. 1993 Feb;78(2):188-91. doi: 10.3171/jns.1993.78.2.0188.
PubMed 8421201Barber M, Stott DJ. Validity of the Telephone Interview for Cognitive Status (TICS) in post-stroke subjects. Int J Geriatr Psychiatry. 2004 Jan;19(1):75-9. doi: 10.1002/gps.1041.
PubMed 14716702de Jager CA, Budge MM, Clarke R. Utility of TICS-M for the assessment of cognitive function in older adults. Int J Geriatr Psychiatry. 2003 Apr;18(4):318-24. doi: 10.1002/gps.830.
PubMed 12673608MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950RANKIN J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957 May;2(5):200-15. doi: 10.1177/003693305700200504. No abstract available.
PubMed 13432835Flibotte JJ, Hagan N, O'Donnell J, Greenberg SM, Rosand J. Warfarin, hematoma expansion, and outcome of intracerebral hemorrhage. Neurology. 2004 Sep 28;63(6):1059-64. doi: 10.1212/01.wnl.0000138428.40673.83.
PubMed 15452298Goldstein JN, Fazen LE, Snider R, Schwab K, Greenberg SM, Smith EE, Lev MH, Rosand J. Contrast extravasation on CT angiography predicts hematoma expansion in intracerebral hemorrhage. Neurology. 2007 Mar 20;68(12):889-94. doi: 10.1212/01.wnl.0000257087.22852.21.
PubMed 17372123Kumar MA, Rost NS, Snider RW, Chanderraj R, Greenberg SM, Smith EE, Rosand J. Anemia and hematoma volume in acute intracerebral hemorrhage. Crit Care Med. 2009 Apr;37(4):1442-7. doi: 10.1097/CCM.0b013e31819ced3a.
PubMed 19242340Brott T, Broderick J, Kothari R, Barsan W, Tomsick T, Sauerbeck L, Spilker J, Duldner J, Khoury J. Early hemorrhage growth in patients with intracerebral hemorrhage. Stroke. 1997 Jan;28(1):1-5. doi: 10.1161/01.str.28.1.1.
PubMed 8996478Davis SM, Broderick J, Hennerici M, Brun NC, Diringer MN, Mayer SA, Begtrup K, Steiner T; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators. Hematoma growth is a determinant of mortality and poor outcome after intracerebral hemorrhage. Neurology. 2006 Apr 25;66(8):1175-81. doi: 10.1212/01.wnl.0000208408.98482.99.
PubMed 16636233
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH)
- ClinicalTrials.gov ID
- NCT01202864
- Acronym / sponsor ID
- ERICH / 1008059
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, ICH, Stroke, Cerebrovascular accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Columbia University, University of Maryland, Georgetown University, Wake Forest University, Emory University, University of Miami, University of Illinois Chicago, University of Texas, Southwestern Medical Center at Dallas, The University of Texas Health Science Center, Houston, The University of Texas Health Science Center at San Antonio, University of New Mexico, University of Arizona, University of Southern California, St. Luke's-Roosevelt Hospital Center, University of California, San Francisco, Duke University, University of Virginia, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find risk factors for hemorrhagic stroke, specifically intracerebral hemorrhage (ICH), among Caucasians, African Americans, and Hispanics.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –3000 Cases |
| Controls | – | –3000 Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our purpose is to enroll 1000 cases of ICH among whites, 1000 cases of ICH among blacks, and 1000 cases of ICH among Hispanics. 3000 controls matched to cases by race/ethnicity, age (+/- 5 years), gender, and geographic location.
Key inclusion criteria (5 listed)
- Age 18 years or greater, fulfillment of the criteria for intracerebral hemorrhage
- Resident for at least 6 months within 50 miles of the recruiting center
- No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of the hemorrhage
- Ability of the patient or legal representative to provide informed consent
Key exclusion criteria (3 listed)
- Malignancies leading to coagulopathy
- Hemorrhagic transformation of ischemic infarct
- Hemorrhage secondary to dural venous sinus thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 8784113Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. doi: 10.1161/01.str.27.9.1459.
- Background: PubMed 11988589Woo D, Sauerbeck LR, Kissela BM, Khoury JC, Szaflarski JP, Gebel J, Shukla R, Pancioli AM, Jauch EC, Menon AG, Deka R, Carrozzella JA, Moomaw CJ, Fontaine RN, Broderick JP. Genetic and environmental risk factors for intracerebral hemorrhage: preliminary results of a population-based study. Stroke. 2002 May;33(5):1190-5. doi: 10.1161/01.str.0000014774.88027.22.
- Background: PubMed 14757893Kissela B, Schneider A, Kleindorfer D, Khoury J, Miller R, Alwell K, Woo D, Szaflarski J, Gebel J, Moomaw C, Pancioli A, Jauch E, Shukla R, Broderick J. Stroke in a biracial population: the excess burden of stroke among blacks. Stroke. 2004 Feb;35(2):426-31. doi: 10.1161/01.STR.0000110982.74967.39.
- Background: PubMed 12843343Hardie K, Hankey GJ, Jamrozik K, Broadhurst RJ, Anderson C. Ten-year survival after first-ever stroke in the perth community stroke study. Stroke. 2003 Aug;34(8):1842-6. doi: 10.1161/01.STR.0000082382.42061.EE. Epub 2003 Jul 3.
- Background: PubMed 2718196Broderick JP, Phillips SJ, Whisnant JP, O'Fallon WM, Bergstralh EJ. Incidence rates of stroke in the eighties: the end of the decline in stroke? Stroke. 1989 May;20(5):577-82. doi: 10.1161/01.str.20.5.577.
- Background: PubMed 8421201Broderick JP, Brott T, Tomsick T, Miller R, Huster G. Intracerebral hemorrhage more than twice as common as subarachnoid hemorrhage. J Neurosurg. 1993 Feb;78(2):188-91. doi: 10.3171/jns.1993.78.2.0188.
- Background: PubMed 14716702Barber M, Stott DJ. Validity of the Telephone Interview for Cognitive Status (TICS) in post-stroke subjects. Int J Geriatr Psychiatry. 2004 Jan;19(1):75-9. doi: 10.1002/gps.1041.
- Background: PubMed 12673608de Jager CA, Budge MM, Clarke R. Utility of TICS-M for the assessment of cognitive function in older adults. Int J Geriatr Psychiatry. 2003 Apr;18(4):318-24. doi: 10.1002/gps.830.
- Background: PubMed 14258950MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
- Background: PubMed 13432835RANKIN J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957 May;2(5):200-15. doi: 10.1177/003693305700200504. No abstract available.
- Background: PubMed 15452298Flibotte JJ, Hagan N, O'Donnell J, Greenberg SM, Rosand J. Warfarin, hematoma expansion, and outcome of intracerebral hemorrhage. Neurology. 2004 Sep 28;63(6):1059-64. doi: 10.1212/01.wnl.0000138428.40673.83.
- Background: PubMed 17372123Goldstein JN, Fazen LE, Snider R, Schwab K, Greenberg SM, Smith EE, Lev MH, Rosand J. Contrast extravasation on CT angiography predicts hematoma expansion in intracerebral hemorrhage. Neurology. 2007 Mar 20;68(12):889-94. doi: 10.1212/01.wnl.0000257087.22852.21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Woo, MD, MS principal investigator
University of Cincinnati
Matthew Flaherty, MD principal investigator
University of Cincinnati
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by University of Cincinnati at 15 sites in United States.
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 5 inclusion and 3 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 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01202864, which also lists 23 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 1 Sep 2017.