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Effect of Perioperative Iron Treatment on Allogenic Blood Transfusion

Primary Purpose

Patient Blood Management, Cardiac Surgery, Iron Deficiency Anemia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Iron Sucrose, recombinant human erythropoietin, ascorbic acid
Iron sucrose
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patient Blood Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years and above
  • Ferritin <300µg/L, transferrin saturation <20%, Hb <130g/L in men or Hb <120g/L in women
  • Patients assessed as being at cardiovascular risk by the anaesthesia clinic （RCRI ≥ 1 point）
  • Major elective non-cardiac surgery: Abdominal surgery: radical resection of upper digestive tract and colorectal tumors, radical resection of pancreatic duodenal tumors, etc. Orthopedics: fracture trauma, large joint replacement, scoliosis correction, radical resection of bone tumor, etc.

Exclusion Criteria:

  • Allergy or contraindication to iron sucrose or recombinant human erythropoietin
  • Patients with body temperature >37.5 ℃ or using non-prophylactic antibiotics
  • Pregnancy or lactation
  • Weight 50 kg or less
  • Minimally invasive (laparoscopic, arthroscopic, etc.) surgery
  • Chronic liver disease and/or screening alanine/aspartate transferase higher than 3 times or more of the upper limit of the normal range
  • Family history of haemochromatosis or thalassaemia or transferrin saturation >50%
  • Other known haematological diseases (folic acid or vitamin B12 deficiency ， hemolytic anemia, hemoglobinopathy, etc.)
  • Known history of iron overload
  • Critically ill patients with ASA≥4 before surgery
  • History of receiving erythropoietin, blood transfusions or intravenous iron within 12 weeks prior to surgery

Sites / Locations

  • The Second Affiliated Hospital of Zhejiang University Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iron treatment intervention arm

control arm

Arm Description

Outcomes

Primary Outcome Measures

Perioperative allogeneic red blood cell infusion rate
Perioperative allogeneic red blood cell infusion rate

Secondary Outcome Measures

Amount of allogeneic blood products used in the perioperative period
(red blood cells, plasma, platelets)
Effect of combination therapy on changes in perioperative haemoglobin levels
Pre-intervention versus post-operative haemoglobin
Effect of combination therapy on changes in perioperative ferritin levels
Pre-intervention versus post-operative ferritin
Effect of combination therapy on changes in perioperative reticulocyte levels
Magnitude of reticulocyte elevation
Incidence of perioperative acute renal insufficiency
Postoperative creatinine more than 2 times higher than preoperative or oliguria (<0.5ml/kg/h) within 12 hours
Post-operative intensive care unit stay
Length of stay in ICU after surgery
Infusion reactions and allergies
Perioperative allergic events
Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery
Myocardial infarction、Ischemic cerebral infarction、arrhythmia、Deep vein thrombosis of the lower extremity、Pulmonary embolism, etc
All-cause mortality within 6 months of surgery
Incidence of mortality
Total length of hospital stay
Total length of hospital stay
Incidence of perioperative infections
Non-prophylactic use of antibiotics
Health Care Costs
All medical costs during hospitalisation
Post-operative hospital readmission rate
Post-operative hospital readmission rate

Full Information

First Posted
April 19, 2022
Last Updated
April 16, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05353348
Brief Title
Effect of Perioperative Iron Treatment on Allogenic Blood Transfusion
Official Title
Iron Sucrose Combined With rHuEPO and Ascorbic Acid on Perioperative Allogeneic Red Blood Cell Infusion in Patients Undergoing Elective Major Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

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

5. Study Description

Brief Summary
This study was designed to investigate the effect of iron sucrose combined with rHuEPO and ascorbic acid on perioperative allogeneic red blood cell transfusion in patients undergoing elective major cardiac surgery by evaluating outcome indicators such as perioperative allogeneic red blood cell transfusion rates and changes in perioperative haemoglobin levels.
Detailed Description
Perioperative anaemia is one of the most common comorbidities in patients undergoing surgery, with a prevalence of up to 30% in patients undergoing cardiac surgery. Perioperative anaemia can lead to ischaemia and hypoxia in vital organs, increased postoperative complications and even increased mortality; in addition to an increased rate of allogeneic blood product transfusions and significantly longer ICU and hospital stays. Correcting perioperative anaemia and reducing complications are of great importance to improve the immediate and long-term prognosis of patients undergoing major cardiac surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Blood Management, Cardiac Surgery, Iron Deficiency Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iron treatment intervention arm
Arm Type
Experimental
Arm Title
control arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Iron Sucrose, recombinant human erythropoietin, ascorbic acid
Intervention Description
During the 1 week period following admission, 3 consecutive dosing regimens were administered, 200 mg of iron sucrose by intravenous infusion at 8am daily in combination with 150 IU/kg of recombinant human erythropoietin by subcutaneous injection and 2 g of ascorbic acid by intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Iron sucrose
Intervention Description
Within 1 week of admission, 3 consecutive combination regimens of 200mg of iron sucrose and saline combined with subcutaneous saline infusions at 8am daily
Primary Outcome Measure Information:
Title
Perioperative allogeneic red blood cell infusion rate
Description
Perioperative allogeneic red blood cell infusion rate
Time Frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Secondary Outcome Measure Information:
Title
Amount of allogeneic blood products used in the perioperative period
Description
(red blood cells, plasma, platelets)
Time Frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Title
Effect of combination therapy on changes in perioperative haemoglobin levels
Description
Pre-intervention versus post-operative haemoglobin
Time Frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Title
Effect of combination therapy on changes in perioperative ferritin levels
Description
Pre-intervention versus post-operative ferritin
Time Frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Title
Effect of combination therapy on changes in perioperative reticulocyte levels
Description
Magnitude of reticulocyte elevation
Time Frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Title
Incidence of perioperative acute renal insufficiency
Description
Postoperative creatinine more than 2 times higher than preoperative or oliguria (<0.5ml/kg/h) within 12 hours
Time Frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Title
Post-operative intensive care unit stay
Description
Length of stay in ICU after surgery
Time Frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Title
Infusion reactions and allergies
Description
Perioperative allergic events
Time Frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Title
Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery
Description
Myocardial infarction、Ischemic cerebral infarction、arrhythmia、Deep vein thrombosis of the lower extremity、Pulmonary embolism, etc
Time Frame
Through study completion, an average of 1.5 year
Title
All-cause mortality within 6 months of surgery
Description
Incidence of mortality
Time Frame
Through study completion, an average of 1.5 year
Title
Total length of hospital stay
Description
Total length of hospital stay
Time Frame
Through study completion, an average of 1 year
Title
Incidence of perioperative infections
Description
Non-prophylactic use of antibiotics
Time Frame
Through study completion, an average of 1 year
Title
Health Care Costs
Description
All medical costs during hospitalisation
Time Frame
From admission until hospital discharge or postoperative day 30, whichever comes first
Title
Post-operative hospital readmission rate
Description
Post-operative hospital readmission rate
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and above Ferritin <300µg/L, transferrin saturation <25%, male 90<Hb<130g/L or female 90<Hb<120g/L Elective major cardiac surgery (valve replacement, CABG coronary artery bypass surgery or a combination of both) ASA: Grade 1-3 Signed informed consent Exclusion Criteria: Allergy or contraindication to iron sucrose or recombinant human erythropoietin or ascorbic acid Patients with a preoperative temperature >37.5 °C or on non-prophylactic antibiotics Pregnancy or breastfeeding stage weight ≤ 50 kg Presence of chronic renal insufficiency, urinary stones, oxalate deposits, gout Chronic liver disease and/or screening alanine transferase/aspartate transferase above normal 3 times or more above the upper limit of the normal range Family history of haemochromatosis, thalassaemia or transferrin saturation > 50% Known history of iron overload Other known causes of anaemia (folic acid or vitamin B12 deficiency or haemoglobinopathies, etc.) Emergency surgery Use of iron, blood transfusion or related anaemia treatment within 12 weeks prior to surgery Withdrawal criteria: massive blood transfusion (≥ 10 red blood cells (RBC)/24h) Preoperative interventions not performed according to standard Cancellation of surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Yan
Phone
13757118632
Email
zryanmin@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University Medical College
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor
Phone
15888210247
Email
zryanmin@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Perioperative Iron Treatment on Allogenic Blood Transfusion

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