Status:
UNKNOWN
Preoperative Intravenous Iron Infusion to Reduce Post-surgical Complications: a Pilot Randomised Control Trial
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Duke-NUS Graduate Medical School
Conditions:
Anemia
Major Abdominal Surgery
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03295851
Start Date
November 22 2017
End Date
March 1 2019
Last Update
December 5 2018
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608