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NCT Number: NCT00598572

Dose Finding and Safety Study of Deferoxamine in Patients With Brain Hemorrhage

Animal studies show that the breakdown of blood results in iron accumulation in the brain after brain hemorrhage (ICH); and that iron plays a role in brain injury in ICH patients. Deferoxamine (DFO) has been extensively used in clinical practice for more than 30 years to remove excessive iron from the body, and has been shown to provide some benefit in animal studies of ICH. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with DFO in patients with ICH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with DFO can improve the outcome of patients with ICH.

Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of DFO, by determining the treatment related adverse events, in patients with ICH; and 2) to determine the maximal tolerated dose to be adopted in subsequent studies to test the efficacy of DFO in improving outcome after ICH.

We hypothesize that DFO is well-tolerated and has minimal serious adverse effects in patients with ICH; and that treatment with DFO will improve patients' outcome. The results can potentially bring into account new means to improve the outcome of patients with ICH. ICH is a frequent cause of disability and death. A successful study demonstrating the efficacy of iron-modifying therapy would be of considerable public health significance.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

An open-label, safety, tolerability, and dose-finding study using the continuous reassessment method.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • The diagnosis of ICH is confirmed by brain CT scan.
  • The first dose of the study drug can be administered within 18 hours of ICH symptom onset.
  • Signed and dated informed consent is obtained
  • Stable clinical and neurological status. Patients whose clinical or neurological status significantly deteriorates compared to presentation prior to administration of the study drug will be excluded.

Exclusion criteria

  • Previous chelation therapy or known hypersensitivity to DFO products
  • Abnormal renal function (serum creatinine > 2 mg/dl)
  • Known severe iron deficiency anemia
  • Planned surgical evacuation of ICH prior to administration of the study drug
  • Patients with suspected secondary ICH related to tumour, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis
  • Evidence of significant shift of midline brain structure (> 10 mm) or herniation on imaging studies.
  • Deep coma (Glasgow Coma Score (GCS) = 3-5) upon presentation
  • Taking iron supplements or prochlorperazine
  • Patients with heart failure taking > 500 mg of vitamin C daily
  • Known hearing impairment
  • Systolic blood pressure < 100 mmHg or diastolic blood pressure < 60 mmHg, confirmed by 3 consecutive readings
  • Significant chronic respiratory insufficiency
  • Known pregnancy (or positive pregnancy test), or breast-feeding
  • Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, incompliance, or any other cause.
  • Any condition which, in the judgement of the investigator, might increase the risk to the patient
  • Life expectancy of less than 90 days due to co-morbid conditions
  • Concurrent participation in another research protocol for investigation of another experimental therapy
  • Pre-existing Do Not Resuscitate (DNR) order, or indication that a new DNR order will be implemented within the first 48 hours of hospitalization. -

Treatment and study plan

Deferoxamine Mesylate

Drug

Various dose-regimens ranging from 7 mg/kg to 125 mg/kg (with a maximum allowable total daily dose of 6000 mg at any of the tested dose tiers, regardless of patient's weight), administered daily by IV infusion for three consecutive days.

Primary outcomes

  1. Dose-limiting toxicities

    Time frame: First 7 days of hospitalization or diacharge, whichever occurs earlier

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Hartford Hospital
  • Massachusetts General Hospital
  • Medical College of Wisconsin
  • Medical University of South Carolina
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Safety and Tolerability of Deferoxamine in Acute Cerebral Hemorrhage

Acronym: DFO In ICH

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2008
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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