Clinical trial NCT02054117: Association Between Haptoglobin Genotype and Brain Swelling
Official title: Association Between Haptoglobin Genotype and the Development of Perihematomal Edema After Spontaneous Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intracerebral Hemorrhage
Keywords: Hemorrhage
Intracerebral hemorrhage (ICH)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from within the hospital setting.

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.

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.)

Primary outcomes:
measure: Perihematomal Edema Volume
timeFrame: Post-hemmorhage day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Spiros Blackburn, MD
role: PRINCIPAL_INVESTIGATOR
References: