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Preoperative Intravenous Iron Infusion to Reduce Post-surgical Complications: a Pilot Randomised Control Trial (PIRCAS)

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ClinicalTrials.gov Identifier: NCT03295851
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

Preoperative anemia is common worldwide, ranging from 25% in knee arthroplasties to 60% in colorectal malignancies. In Singapore, about a quarter (27%) of all patients have anaemia prior to operation at a main tertiary center. Currently, the rate of preoperative anemia in Singapore General Hospital (SGH) is 26.6%.

This is an alarming public health issue as the negative impact of preoperative anemia on post-surgical outcomes has been well documented and include increased rates of perioperative blood transfusion, mortality, adverse cardiac and non-cardiac complications including pulmonary complications, wound infections, systemic sepsis and venous thromboembolism, as well as prolonged length of hospital stay and increased healthcare costs. These data suggest that reducing preoperative anemia prior to major surgery is imperative to improve clinical outcomes and decrease healthcare costs.

This study responds to an urgent need to optimize the current standard practice for managing preoperative anemia. It is designed as a randomised, open-label, study to investigate the efficacy of intravenous iron compared to oral iron in patients with anemia undergoing major surgery to reduce surgical complications. To demonstrate the feasibility of conducting such trial in a larger scale, a pilot study with the same design will be conducted. The findings of this pilot study will also inform the study design and sample size for the larger study.

If successful, the results will inform clinical practice guidelines, result in better patient and clinical outcomes, reduce burden on the health care system, and change health-related policy. For example, all forms of intravenous iron therapy are currently not subsidized by the Singapore government which is in stark contrast with allogenic blood transfusion, which is subsidised and readily available at a substantially reduced rate to patients. Hence, it will cost the patients more out of pocket to be treated with intravenous iron than to have allogenic blood transfusion. Incorporating a preoperative anemia correction protocol in the current surgical pathway is a potential strategy to combat healthcare cost inflation and the increasing demand for blood products.


Condition or disease Intervention/treatment Phase
Anemia Major Abdominal Surgery Pre-operative Drug: Ferric carboxymaltose Drug: Ferrous Fumarate Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative, Single-dose Intravenous Iron Formulation to Reduce Post-surgical Complications in Patients Undergoing Major Abdominal Surgery: a Pilot Randomised Control Trial (PIRCAS Trial - Pilot)
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: IV Ferric Carboxymaltose
Patients in the intervention group will receive preoperative IV ferric carboxymaltose, given as a single dose (15 mg/kg body weight, to a maximum dose of 1000 mg) over 30 minutes.
Drug: Ferric carboxymaltose
Patients in the intervention group will receive preoperative IV ferric carboxymaltose, given as a single dose (15 mg/kg body weight, to a maximum dose of 1000 mg) over 30 minutes.
Other Name: IV Iron

Active Comparator: Oral Ferrous Fumarate
Patients will be given oral iron as per current clinical protocol, which is Ferrous fumarate 200mg twice daily
Drug: Ferrous Fumarate
Patients will be given oral iron as per current clinical protocol, which is Ferrous fumarate 200mg twice daily.
Other Name: Oral Iron




Primary Outcome Measures :
  1. Feasibility of the study [ Time Frame: four months ]

    The study can be conducted feasibly at the research site as evidence by:

    1. Number of participants who receive study drug within 5 days of enrollment
    2. Number of participants recruited over 4 months
    3. Number of participants completed the study


Secondary Outcome Measures :
  1. effectiveness of a single preoperative dose of IV FCM in treating iron deficiency anemia [ Time Frame: one month ]
    Change in hemoglobin level

  2. the effect of intravenous FCM compared with oral iron on mortality [ Time Frame: six month ]
    all-cause death

  3. the effect of intravenous FCM compared with oral iron on perioperative morbidities [ Time Frame: six month ]
    length of hospital stay

  4. the effect of intravenous FCM compared with oral iron on health related quality of life [ Time Frame: three month ]
    EQ-5D questionnaires

  5. the effect of intravenous FCM compared with oral iron on post operative morbidities [ Time Frame: six months ]
    Postoperative morbidites will be collected using PostOperative Morbidity Survey (POMS) and classified using Clavien-Dindo grading of complications



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective major benign or malignant abdominal surgery
  • Procedures expected to last 2 hours and/or more OR Anticipated blood loss greater than 500ml
  • PAC clinic scheduled before 1 - 4 weeks before surgery
  • Male Hb less than 13.0 Gram Per Deciliter OR Female Hb less than 12.0 Gram Per Deciliter
  • Diagnosed as having Iron Deficiency: Serum Ferritin level less than 100 Microgram Per Liter OR Serum Ferritin is between less than100 Microgram Per Liter - less than 300 Microgram Per Liter + Transferrin Saturation is less than 20 percent
  • Patient is able to receive the infusion 1 - 4 Weeks [at least 7 Days] before the planned operation date.
  • Patient is able to provide written, informed consent

Exclusion Criteria:

  • Know history of acquired iron overload
  • Family history of hemochromatosis or thalassemia or transferrin saturation (TSAT) more than 50 percent
  • Treatment with erythropoietin in the previous 12 weeks (3months)
  • Known hypersensitivity to Ferric Carboxymaltose or its excipients
  • Patients with severe asthma or severe allergy (requiring hospitalization within the last 12 months)
  • Pregnancy
  • Age less than 21 years
  • Inability to communicate or understand study instructions and questionnaire which will be provided in either English, Chinese, Malay or Tamil
  • Patient involvement in another Investigational Medicinal Product Trial within the previous 4 weeks prior to randomization that may impact the results of the PIRCAS trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295851


Contacts
Contact: Hairil Rizal Abdullah 006563265428 hairil.rizal.abdullah@singhealth.com.sg
Contact: Thiri Naing Thin 006563265428 thin.thiri.naing@sgh.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Hairil Rizal Abdullah, PI    006563265428    hairil.rizal.abdullah@singhealth.com.sg   
Contact: Thiri Naing Thin, Research Nurse    006563265428    thin.thiri.naing@sgh.com.sg   
Sub-Investigator: Eileen SIm         
Sponsors and Collaborators
Singapore General Hospital
Duke-NUS Graduate Medical School
Investigators
Principal Investigator: Hairil Rizal Abdullah Singapore General Hospital

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03295851     History of Changes
Other Study ID Numbers: FCM001
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Singapore General Hospital:
Anemia
Pre-operative
Intravenous Iron
Ferric carboxymaltose
abdominal surgery

Additional relevant MeSH terms:
Iron
Ferrous fumarate
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics