Study Stopped
Principal Investigator is leaving institution.
Association Between Haptoglobin Genotype and Brain Swelling
1 other identifier
observational
9
1 country
1
Brief Summary
Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early phase involves the mechanical compression of brain tissue by the expanding hematoma. In a later phase, brain swelling develops causing further compression that may lead to brain herniation and death. This study investigates the neuroprotective role of haptoglobin, in minimizing the development of brain swelling following intracerebral hemorrhage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 5, 2015
March 1, 2015
1 year
February 3, 2014
March 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perihematomal Edema Volume
Perihematomal edema will be measured by averaging the edema area over multiple slices and subtracting the hemorrhage area from the total lesion area.
Post-hemmorhage day 3
Study Arms (1)
Intracerebral Hemorrhage
Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.
Interventions
Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.
Eligibility Criteria
Participants will be recruited from within the hospital setting.
You may qualify if:
- Spontaneous intracranial or intraparenchymal hemorrhage
- years of age
- Hemorrhage occurred in a supratentorial location
You may not qualify if:
- Inability to obtain consent within 3 days of hemorrhage onset
- Known pregnancy
- Therapeutic anticoagulation with Lovenox, Coumadin or Heparin
- Prior history of therapeutic radiation to any area
- Brain tumor
- Hemorrhage related to trauma, aneurysm, arteriovenous malformation or other vascular malformation
- Central nervous system infection
- Subdural hematoma
- Subarachnoid hemorrhage
- Chronic immunosuppression, including steroids or chemotherapy agents
- Infratentorial location
- Unable to obtain MRI due to mental status or other contraindication (metal, pacemaker, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Spiros Blackburn, MD
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2014
First Posted
February 4, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
March 5, 2015
Record last verified: 2015-03