CClinicalTrials.gg
TerminatedNCT02054117Updated Mar 5, 2015

Association Between Haptoglobin Genotype and Brain Swelling

An observational study in Intracerebral Hemorrhage, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-03-05.

Sponsored by University of Florida · Observational

Why this study was terminated
Principal Investigator is leaving institution.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
9
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intracerebral Hemorrhage

Keywords

  • Hemorrhage
  • Intracerebral hemorrhage (ICH)
03

In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's enrollment of 9 is below the median of 275 across 180 observational studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be recruited from within the hospital setting.

Inclusion criteria

  • Spontaneous intracranial or intraparenchymal hemorrhage
  • 18-85 years of age
  • Hemorrhage occurred in a supratentorial location

Exclusion criteria

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.)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
9 participants (actual)
Patient registry
No

Groups and cohorts

  • Intracerebral Hemorrhage

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

    Other: Intracerebral Hemorrhage

Interventions

  • OtherIntracerebral Hemorrhage

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

    Also known as: Spontaneious intracranial hemorrhage, Intraparenchymal hemorrhage

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Post-hemmorhage day 3

07

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32610, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02054117
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Feb 4, 2014
Start date
Mar 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Mar 5, 2015

Study contacts

Spiros Blackburn, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion