Association Between Haptoglobin Genotype and Brain Swelling

Terminated

• Conditions: Intracerebral Hemorrhage
• Interventions: Other: Intracerebral Hemorrhage

• Registration Number: NCT02054117
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-04
• Study Start: 2014-03
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

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

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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.)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intracerebral Hemorrhage	Intracerebral Hemorrhage	Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.

Primary Outcome Measures

Name	Time	Method
Perihematomal Edema Volume	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States