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Association Between Haptoglobin Genotype and Brain Swelling

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ClinicalTrials.gov Identifier: NCT02054117
Recruitment Status : Terminated (Principal Investigator is leaving institution.)
First Posted : February 4, 2014
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Intracerebral Hemorrhage Other: Intracerebral Hemorrhage

Detailed Description:
Intracerebral hemorrhage is bleeding into the brain parenchyma. It is a major cause of stroke, and is associated with significant morbidity and mortality. 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 edema, especially perihematomal edema, develops causing further compression that may lead to brain herniation and death. Several factors are implicated in the development of brain edema, including inflammation resulting from the oxidative stress caused by iron-rich hemoglobin released from lysed erythrocytes in brain tissue. This study investigates the neuroprotective role of an acute phase reactant, haptoglobin, in minimizing the development of perihematomal edema following intracerebral hemorrhage. This protein protects brain tissue from hemoglobin degradation products by forming haptoglobin-hemoglobin complexes that are subsequently cleared by the spleen. Notably, different alleles of haptoglobin exist in humans, with varying affinities for hemoglobin. Investigating the association between the different alleles and the degree of perihematomal edema formation is the primary goal of this study. The investigators will also look at a marker of inflammation, matrix metalloproteinases, and analyze its level of expression in subjects with different alleles of haptoglobin.

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Association Between Haptoglobin Genotype and the Development of Perihematomal Edema After Spontaneous Intracerebral Hemorrhage
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Edema

Group/Cohort Intervention/treatment
Intracerebral Hemorrhage
Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.
Other: Intracerebral Hemorrhage
Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.
Other Names:
  • Spontaneious intracranial hemorrhage
  • Intraparenchymal hemorrhage




Primary Outcome Measures :
  1. Perihematomal Edema Volume [ Time Frame: Post-hemmorhage day 3 ]
    Perihematomal edema will be measured by averaging the edema area over multiple slices and subtracting the hemorrhage area from the total lesion area.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from within the hospital setting.
Criteria

Inclusion Criteria:

  • Spontaneous intracranial or intraparenchymal hemorrhage
  • 18-85 years of age
  • Hemorrhage occurred in a supratentorial location

Exclusion Criteria:

  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054117


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Spiros Blackburn, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02054117     History of Changes
Other Study ID Numbers: 201300797
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015
Keywords provided by University of Florida:
Hemorrhage
Intracerebral hemorrhage (ICH)
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases