Safety of Darbepoetin Alfa Treatment in Patients With Severe Traumatic Brain Injury

NCT00375869 | Completed Phase 2

• 1 other identifier: TBI2006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to see if the treatment of severely brain injured patients with darbepoetin (a long acting form of erythropoietin) will be safe, and will reduce brain damage by decreasing harmful levels of chemicals in the brain.

Conditions

Traumatic Brain Injury

Keywords

Neuroprotection; neuron specific enolase; CSF glutamate levels; Darbepoetin Alfa

Outcome Measures

Primary Outcomes (1)

• Neuron-specific serum enolase, CSF glutamate and CSF S100B levels in patients receiving darbepoetin compared to placebo

  The primary outcome measures include Neuron-specific serum enolase, CSF glutamate and CSF S100B levels in patients receiving darbepoetin compared to placebo over a 96 hour period and ICP levels in patients receiving darbepoetin compared to placebo over a 96 hour period

  over 96 hours

Secondary Outcomes (1)

• Secondary outcome measures include ICU and hospital length of stay, GCS at ICU discharge, survival status, location after ICU and hospital discharge. GCS will be evaluated at day 28 and 1 year.

  day 28 and 1 year

Study Arms (2)

Darbopoeitin

ACTIVE COMPARATOR

The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.

Drug: Darbeopoetin

Normal Saline (Placebo)

PLACEBO COMPARATOR

The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.

Drug: Normal Saline (Placebo)

Interventions

Darbeopoetin DRUG

The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.

Also known as: ARANESP

Darbopoeitin

Normal Saline (Placebo) DRUG

The treatment group, comprised of ten patients, will receive an intravenous dose of 200 mcg (1 ml) of darbepoetin (Aranesp®). Patients will be randomly assigned to either the treatment group, or the control group in a 2:1 ratio. The treatment group will be given 200 mcg of darbepoetin intravenously. The control group will be given a matching placebo of 1 mL of normal saline.

Also known as: Placebo

Normal Saline (Placebo)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 inclusive.
• Admitted to ICU with a TBI and a GCS ≤ 8 with a motor score \< 6.
• Patient must have a functioning external ventricular drain in place for intracranial pressure (ICP) monitoring.
• Completion of informed consent by the next-of-kin or legal guardian.
• Randomization within 12 hours of initial triage by medical or paramedical staff.
• Abnormal CT of the brain.

You may not qualify if:

• Pregnancy
• Cardiac arrest during the current hospital admission.
• Bilateral non-reactive dilated pupils at the time of randomization.
• A history of renal failure, NYHA class IV congestive heart failure, or recent myocardial infarction (within 6 months).
• A history of primary or secondary polycythemia.
• Previous adverse reactions to rhEPO or darbepoetin.
• Previous history of seizure disorder.
• Recent history (within the past 3 months) of significant uncontrolled hypertension defined as SBP \> 200 mm Hg or DBP \> 110 mmHg.
• Patients involved in other clinical investigations involving therapeutic interventions
• Hemoglobin ≥150 g/L in females
• Hemoglobin ≥160g/L in males
• Past history of thrombotic events

Sponsors & Collaborators

• Royal Alexandra Hospital: lead
• University of Alberta: collaborator

Study Sites (2)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Darbepoetin alfa; Saline Solution

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Demetrios J. Kutsogiannis, MD MHS FRCPC

  Division of Critical Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MHS, FRCPC

Study Record Dates

• First Submitted: September 12, 2006
• First Posted: September 13, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 5, 2012

Record last verified: 2012-03

Locations

CA (2)