Association Between Haptoglobin Genotype and Brain Swelling

NCT ID: NCT02054117

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Intracerebral Hemorrhage

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Intracerebral Hemorrhage

Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.

Intracerebral Hemorrhage

Intervention Type: OTHER

Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.

Interventions

Intracerebral Hemorrhage

Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.

Intervention Type: OTHER

Other Intervention Names

Spontaneious intracranial hemorrhage; Intraparenchymal hemorrhage

Eligibility 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Spiros Blackburn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

201300797

Identifier Type: -

Identifier Source: org_study_id