NCT01912261

Brief Summary

The purpose of this research study is to examine how an oral iron supplement (Feramax®) influences fatigue during early postoperative recovery (at three months) among CABG patients and, the effects on recovery outcomes (e.g. quality of life, functional capacity, anemia, and medication adherence). It is hypothesized that CABG surgery patients receiving oral iron (Feramax®) 150mg orally (once a day therapy) will have a 15% reduction in POF (measured by the Identity Consequence Fatigue Scale (ICFS)), compared to patients receiving a placebo.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 16, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

3.2 years

First QC Date

July 29, 2013

Last Update Submit

July 24, 2019

Conditions

Fatigue

Keywords

Coronary artery bypass graftingAnemiaPostoperative fatigueFunctional CapacityIronAdherenceQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Fatigue Level

    Identity Consequence Fatigue scale

    12 weeks after surgery

Secondary Outcomes (4)

  • Health Related Quality of Life

    12 weeks after discharge from hospital

  • Anemia

    12 week after surgery

  • Functional Capacity

    12 weeks after surgery

  • Medication Adherence

    12 weeks after surgery

Study Arms (2)

FeraMax

ACTIVE COMPARATOR

FeraMax Polysaccharide iron complex oral iron supplement 150mg one capsule orally daily

Drug: Polysaccharide iron complex

Placebo

PLACEBO COMPARATOR

one capsule orally daily

Drug: Placebo

Interventions

PlaceboDRUG

one capsule orally daily times 84 days

Also known as: Sugar pill
Placebo
Polysaccharide iron complexDRUG

150 mg daily orally times 84 days

Also known as: FeraMAX
FeraMax

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-Urgent, first time, coronary artery bypass grafting.
  • American Society of Anesthesia (ASA) physical status II-IV
  • Aged 19 years and older
  • Able to make informed consent by understanding the nature of the participation
  • Able to read and write English to the degree necessary to participate in interviews and questionnaires

You may not qualify if:

  • Had prior median sternotomy surgery
  • A Hemoglobin greater than or equal 120g/L at discharge
  • Previous history of noncompliance with oral medications
  • Received erythropoiesis-stimulating agents (e.g. epoetin alfa and darbepoetin alfa) postoperatively to discharge
  • Allergy to iron History of hematological disorders that are deemed clinically significant as per the investigator's clinical judgment
  • History of iron metabolism disorders e.g. known iron overload, hemochromatosis, porphyria
  • Chronic fatigue syndrome (a condition that is distinguished from other types of fatigue by fatigue lasting more than six months and has at least four other symptoms (e.g. sleep disturbances, headaches, joint pain, and concentration difficulties) that could contribute to increased fatigue (Afari \& Buchwald, 2003)).
  • A serum transferrin saturation of more than 50% at discharge
  • History of Fibromyalgia
  • Current diagnosis of depressive disorder
  • History of Hypothyroidism includes uncontrolled thyroid disease (abnormal Thyroid Stimulating Hormone (TSH) or Thyroxine (T4) at screening visit) as per the Investigator's clinical judgment
  • Patient taking iron supplementation ≤ 60 days before surgery and in the postoperative period
  • Any other unstable conditions as per the Investigator's clinical judgment
  • Contraindications to the six-minute walk test
  • Physical disability preventing safe performance
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Health

Halifax, Nova Scotia, B3H3A7, Canada

Location

MeSH Terms

Conditions

FatigueAnemia

Interventions

SugarsNiferex

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Blaine Kent, MD

    Capital Health, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anethesiology

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

December 16, 2014

Primary Completion

February 21, 2018

Study Completion

February 1, 2019

Last Updated

July 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)