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

NCT03295851 | Unknown Phase 4

• 1 other identifier: FCM001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Major Abdominal Surgery; Pre-operative

Keywords

Anemia; Pre-operative; Intravenous Iron; Ferric carboxymaltose; abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Feasibility of the study

  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

  four months

Secondary Outcomes (5)

• effectiveness of a single preoperative dose of IV FCM in treating iron deficiency anemia

  one month

• the effect of intravenous FCM compared with oral iron on mortality

  six month

• the effect of intravenous FCM compared with oral iron on perioperative morbidities

  six month

• the effect of intravenous FCM compared with oral iron on health related quality of life

  three month

• the effect of intravenous FCM compared with oral iron on post operative morbidities

  six months

Study Arms (2)

IV Ferric Carboxymaltose

EXPERIMENTAL

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

Oral Ferrous Fumarate

ACTIVE COMPARATOR

Patients will be given oral iron as per current clinical protocol, which is Ferrous fumarate 200mg twice daily

Drug: Ferrous Fumarate

Interventions

Ferric carboxymaltose DRUG

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.

Also known as: IV Iron

IV Ferric Carboxymaltose

Ferrous Fumarate DRUG

Patients will be given oral iron as per current clinical protocol, which is Ferrous fumarate 200mg twice daily.

Also known as: Oral Iron

Oral Ferrous Fumarate

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose; ferryl iron; ferrous fumarate; Iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Hairil Rizal Abdullah

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hairil Rizal Abdullah

CONTACT

006563265428; hairil.rizal.abdullah@singhealth.com.sg

Thiri Naing Thin

CONTACT

006563265428; thin.thiri.naing@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 28, 2017
• Study Start: November 22, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

SG (1)