Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use of Iron Therapy for Patients With Anemia After Surgery (VITAPOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01975272
Recruitment Status : Unknown
Verified October 2013 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 4, 2013
Last Update Posted : November 4, 2013
Sponsor:
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE September 30, 2013
First Posted Date  ICMJE November 4, 2013
Last Update Posted Date November 4, 2013
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
Hemoglobin [ Time Frame: 3 weeks postoperative ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
  • Quality of life [ Time Frame: 1,3 and 6 weeks postoperative ]
    Quality of life will be determined by using the next questionnaires: European Health Related Quality of Life (euro HRQol) and Multidimensional Fatigue Inventory (MFI)
  • Side effects of medication [ Time Frame: 1,3 and 6 weeks postoperative ]
    In the questionnaire one has to fill out if there are any side effects like Nausea; Stomach ache; constipation; Diarrhea; Skin rash; Headache; Dizziness; Other....
  • Predictive value of other parameters C reactive protein (CRP) ,transferrin, ferritin, hepcidin [ Time Frame: 3 and 6 weeks postoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Iron Therapy for Patients With Anemia After Surgery
Official Title  ICMJE The Value of Iron Treatment for Postoperative Patients With Anemia: a Randomized Double Blind Controlled Trial
Brief Summary The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after gynaecologic surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Anaemia
Intervention  ICMJE
  • Drug: Ferinject
    Other Names:
    • intravenous iron
    • ferric carboxymaltose
  • Drug: Ferrous fumarate
    Other Names:
    • Oral iron
    • Iron (II) fumarate
  • Drug: Placebo for ferrous fumarate
    Other Name: Placebo tablets
  • Drug: Placebo for ferinject
    Other Name: NaCl
Study Arms  ICMJE
  • Active Comparator: Ferinject
    Once an infusion of Ferinject 1000 mg, 1 day after surgery
    Interventions:
    • Drug: Ferinject
    • Drug: Placebo for ferrous fumarate
  • Active Comparator: Ferrous fumarate
    2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery
    Interventions:
    • Drug: Ferrous fumarate
    • Drug: Placebo for ferinject
  • Placebo Comparator: Placebo infusion and tablets
    Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery
    Interventions:
    • Drug: Placebo for ferrous fumarate
    • Drug: Placebo for ferinject
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 28, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gynecological surgery
  • Hb 5-7 mmol/L

Exclusion Criteria:

  • Pregnancy
  • Oncological operations
  • Infections (PID)
  • Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal testing; Hysteroscopies
  • Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ), Conization,
  • Small vulvar / vaginal operations such as (cysts, labia correction)
  • Endometrial ablation
  • Legal incapacity
  • The patient has used pre-operatively an iron preparation and / or blood transfusion or during the surgery
  • Hematologic disorders
  • Erythropoiesis-stimulating agents < 3months ago
  • Myelosuppressive therapy in history
  • Hepatitis
  • HIV
  • Alcohol abuses
  • Not understanding Dutch
  • Allergic reaction to iron therapy in past
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01975272
Other Study ID Numbers  ICMJE METC 12-2-018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Vifor Pharma
Investigators  ICMJE Not Provided
PRS Account Maastricht University Medical Center
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP