Association Between Haptoglobin Genotype and Brain Swelling

Intracerebral Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02054117
• Other study ID #: 201300797
• Status: Terminated
• Phase: N/A
• First received: February 3, 2014
• Last updated: March 4, 2015
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Other:
• Intracerebral Hemorrhage
Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perihematomal Edema Volume	Perihematomal edema will be measured by averaging the edema area over multiple slices and subtracting the hemorrhage area from the total lesion area.	Post-hemmorhage day 3	No