Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01202864
Other study ID # 1008059
Secondary ID R01NS069763-01
Status Completed
Phase N/A
First received September 14, 2010
Last updated August 31, 2017
Start date August 1, 2010
Est. completion date August 1, 2017

Study information

Verified date August 2017
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 6000
Est. completion date August 1, 2017
Est. primary completion date July 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

All cases must meet the following eligibility criteria:

1. Age 18 years or greater, fulfillment of the criteria for intracerebral hemorrhage

2. Resident for at least 6 months within 50 miles of the recruiting center

3. No evidence of trauma, vascular malformation or aneurysm, or brain tumor as a cause of the hemorrhage

4. Ability of the patient or legal representative to provide informed consent

Exclusion Criteria:

Exclusion Criteria:

1. Malignancies leading to coagulopathy

2. Hemorrhagic transformation of ischemic infarct

3. Hemorrhage secondary to dural venous sinus thrombosis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States Emory University Atlanta Georgia
United States University of Maryland Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States University of Illinois Chicago Illinois
United States University of Texas Southwestern Medical Center at Dallas Dallas Texas
United States University of Texas Medical School at Houston Houston Texas
United States University of Southern California Los Angeles California
United States University of Miami Miami Florida
United States University of Miami - Biorepository Miami Florida
United States Columbia University New York New York
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States University of Arizona Tucson Arizona
United States Georgetown University Washington, D.C. District of Columbia
United States Wake Forest University Winston-Salem North Carolina

Sponsors (20)

Lead Sponsor Collaborator
University of Cincinnati Columbia University, Duke University, Emory University, Georgetown University, Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS), St. Luke's-Roosevelt Hospital Center, The University of Texas Health Science Center at San Antonio, The University of Texas Health Science Center, Houston, University of Arizona, University of California, San Francisco, University of Illinois at Chicago, University of Maryland, University of Miami, University of New Mexico, University of Southern California, University of Texas, Southwestern Medical Center at Dallas, University of Virginia, Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (16)

Barber 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. — View Citation

Broderick 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. — View Citation

Broderick 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. — View Citation

Brott 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. — View Citation

Davis 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. — View Citation

de 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. — View Citation

Flibotte 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. — View Citation

Goldstein 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. — View Citation

Hardie 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. Epub 2003 Jul 3. — View Citation

Kissela 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. — View Citation

Kumar 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. — View Citation

MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. — View Citation

Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534. — View Citation

RANKIN J. Cerebral vascular accidents in patients over the age of 60. II. Prognosis. Scott Med J. 1957 May;2(5):200-15. — View Citation

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. Review. — View Citation

Woo 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. — View Citation

* Note: There are 16 references in allClick here to view all references

See also
  Status Clinical Trial Phase
Recruiting NCT05089331 - ROSE-Longitudinal Assessment With Neuroimaging
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Active, not recruiting NCT04522102 - Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral haemorrhaGe (ASPIRING)-Pilot Phase Phase 3
Terminated NCT04178746 - PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
Not yet recruiting NCT03956485 - Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT).
Enrolling by invitation NCT02920645 - Multicenter Validation of the AVICH Score N/A
Recruiting NCT02625948 - Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign Phase 2
Completed NCT02478177 - Addressing Real-world Anticoagulant Management Issues in Stroke
Completed NCT01971359 - Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study N/A
Completed NCT01261091 - Early Tracheostomy in Ventilated Stroke Patients N/A
Terminated NCT00990509 - Albumin for Intracerebral Hemorrhage Intervention Phase 2
Completed NCT00716079 - The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial N/A
Recruiting NCT00222625 - rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets Phase 2
Recruiting NCT05095857 - The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury Phase 4
Recruiting NCT04548596 - NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
Not yet recruiting NCT06429332 - International Care Bundle Evaluation in Cerebral Hemorrhage Research Phase 4
Recruiting NCT05492474 - Cranial Ultrasound for Prehospital ICH Diagnosis N/A
Not yet recruiting NCT05502874 - Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
Recruiting NCT04604587 - MRI-visible Enlarged Perivascular Spaces and the Alteration of Lymphatic Drainage System in CAA Phase 3
Recruiting NCT05504941 - Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage N/A