Association Between Haptoglobin Genotype and Brain Swelling

March 4, 2015 updated by: University of Florida

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from within the hospital setting.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intracerebral Hemorrhage
Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.
Other: Intracerebral Hemorrhage
Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.
Other Names:
  • Spontaneious intracranial hemorrhage
  • Intraparenchymal hemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perihematomal Edema Volume
Time Frame: 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.
Post-hemmorhage day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Spiros Blackburn, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 3, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201300797

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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