Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 9:25 PM
Study NCT ID:
NCT01912261
Status:
TERMINATED
Last Update Posted:
2019-07-26
First Post:
2013-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Oral Iron on Postoperative Fatigue Upon Coronary Artery Bypass Graft Patients
Sponsor:
Nova Scotia Health Authority
Organization:
Study Overview
Official Title:
Phase III Randomized Double Blind Placebo-Controlled Study To Assess The Effects Of FeraMax When Administered Orally Once A Day On Postoperative Fatigue Levels In Patients Following Elective Coronary Artery Bypass Graft Surgery (CABG)
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to time constraints and resources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Postoperative fatigue (POF) is one of the main complaints in approximately 39-80% of CABG surgery patients. POF can have a significant impact on an individual's quality of life (QoL) and recovery. The objectives are to examine how an oral iron (Feramax®) influences fatigue during early postoperative recovery (at three months) among CABG patients and determine the effects on recovery outcomes (e.g. QoL, functional capacity, anemia, and medication adherence). To achieve these objectives the research will aim to answer the following questions:
1. Is oral iron effective in reducing POF measured by the Identity Consequence Fatigue Scale (ICFS) over 12 weeks?
2. If oral iron is effective, how effective was it on improving fatigue, functional capacity, QoL, and anemia?
3. To what degree do patients taking oral iron adhere to the prescription? A prospective, randomized, double-blind placebo-controlled, single-center study was chosen for this study. Three hundred participants who are scheduled for an isolated CABG surgery will be recruited from the QEII Health Sciences Centre (QEIIHSC), Halifax, Nova Scotia. All study participants will be followed for three months following hospital discharge.
Data will be collected at five time points:
Time point 1 Baseline -Patients are screened in the preadmission clinic or nursing unit and recruited for the study. During this visit, the patient will be assessed for eligibility, demographic data and blood work collected and three questionnaires and six minute walk test completed by participants.
Time point 2 Discharge/Randomization-Patients will be randomized to either FeraMAX® or placebo at hospital discharge. The treatment will be taken once daily for 84 days starting Day 1 (day after discharge from hospital). The questionnaires, six minute walk test and blood work will be repeated.
Time point 3 -Post testing 7 to 14 days post discharge A follow up telephone call to reminder patients to take medications and fill put side effects diary
Time Point 4 Six week Follow up-Blood work will be collected and three questionnaires and six minute walk test completed by participants.
Time Point 5-End of treatment-The questionnaires, six minute walk test, blood work, collect side effects diary and pill count will be repeated during a clinic visit.
Fatigue will be measured with the ICFS and Functional Assessment of Cancer Therapy Anemia( FACT-An) questionnaire. The Short Form-36 is used to measure QoL and the six minute walk test to measure functional capacity. Standard of care laboratory tests including (hemoglobin (Hgb) level, reticulocyte count, ferritin, iron, total iron binding capacity (TIBC), transferrin saturation, and C-Reactive Protein levels will be drawn. Medication adherence to the will be assessed by pill count.
The primary endpoint will be analyzed using ANOVA for repeated measures to compare level of fatigue of two groups at baseline, discharge, six weeks and 12 weeks. For the secondary endpoint, a subgroup analysis will be performed and reported on participants with and without iron- deficiency anemia to determine if any efficacy of iron on POF is restricted to this population or to a more general population post CABG surgery. Results will be reported using mean and standard deviation when appropriate and median (interquartile range) for nonparametric data. Categorical variables will be compared using Fisher exact test or t test when appropriate. Level of significance was set at p \< 0.05.
Oral iron is inexpensive and effective treatment for iron deficiency that occurs from surgical blood loss. Currently there is no specific drug used to treat POF. Standard of care for POF consists of treating and eliminating the underlying symptoms.
1. Is oral iron effective in reducing POF measured by the Identity Consequence Fatigue Scale (ICFS) over 12 weeks?
2. If oral iron is effective, how effective was it on improving fatigue, functional capacity, QoL, and anemia?
3. To what degree do patients taking oral iron adhere to the prescription? A prospective, randomized, double-blind placebo-controlled, single-center study was chosen for this study. Three hundred participants who are scheduled for an isolated CABG surgery will be recruited from the QEII Health Sciences Centre (QEIIHSC), Halifax, Nova Scotia. All study participants will be followed for three months following hospital discharge.
Data will be collected at five time points:
Time point 1 Baseline -Patients are screened in the preadmission clinic or nursing unit and recruited for the study. During this visit, the patient will be assessed for eligibility, demographic data and blood work collected and three questionnaires and six minute walk test completed by participants.
Time point 2 Discharge/Randomization-Patients will be randomized to either FeraMAX® or placebo at hospital discharge. The treatment will be taken once daily for 84 days starting Day 1 (day after discharge from hospital). The questionnaires, six minute walk test and blood work will be repeated.
Time point 3 -Post testing 7 to 14 days post discharge A follow up telephone call to reminder patients to take medications and fill put side effects diary
Time Point 4 Six week Follow up-Blood work will be collected and three questionnaires and six minute walk test completed by participants.
Time Point 5-End of treatment-The questionnaires, six minute walk test, blood work, collect side effects diary and pill count will be repeated during a clinic visit.
Fatigue will be measured with the ICFS and Functional Assessment of Cancer Therapy Anemia( FACT-An) questionnaire. The Short Form-36 is used to measure QoL and the six minute walk test to measure functional capacity. Standard of care laboratory tests including (hemoglobin (Hgb) level, reticulocyte count, ferritin, iron, total iron binding capacity (TIBC), transferrin saturation, and C-Reactive Protein levels will be drawn. Medication adherence to the will be assessed by pill count.
The primary endpoint will be analyzed using ANOVA for repeated measures to compare level of fatigue of two groups at baseline, discharge, six weeks and 12 weeks. For the secondary endpoint, a subgroup analysis will be performed and reported on participants with and without iron- deficiency anemia to determine if any efficacy of iron on POF is restricted to this population or to a more general population post CABG surgery. Results will be reported using mean and standard deviation when appropriate and median (interquartile range) for nonparametric data. Categorical variables will be compared using Fisher exact test or t test when appropriate. Level of significance was set at p \< 0.05.
Oral iron is inexpensive and effective treatment for iron deficiency that occurs from surgical blood loss. Currently there is no specific drug used to treat POF. Standard of care for POF consists of treating and eliminating the underlying symptoms.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: