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Association Between Haptoglobin Genotype and Brain Swelling

Association Between Haptoglobin Genotype and the Development of Perihematomal Edema After Spontaneous Intracerebral Hemorrhage

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02054117
Enrollment
9
Registered
2014-02-04
Start date
2014-03-31
Completion date
2015-03-31
Last updated
2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

Keywords

Hemorrhage, Intracerebral hemorrhage (ICH)

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.

Interventions

OTHERIntracerebral Hemorrhage

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

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Perihematomal Edema VolumePost-hemmorhage day 3Perihematomal edema will be measured by averaging the edema area over multiple slices and subtracting the hemorrhage area from the total lesion area.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026