Patient Blood Mangement (PBM) Using IV Iron in Patients With Gynecologic Cancer
A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of Patient Blood Management Program in Patients With Gynecologic Cancer
1 other identifier
interventional
334
1 country
1
Brief Summary
To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2022
CompletedFirst Posted
Study publicly available on registry
January 3, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJanuary 5, 2023
January 1, 2023
2.3 years
November 29, 2022
January 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
transfusion rate
Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment
within 3 weeks after surgery
Secondary Outcomes (7)
hemoglobin differences
within 3 weeks after surgery
Frequency of anemia
within 3 weeks after surgery
Frequency and delay period of treatment
within 3 weeks after surgery
The costs that patients actually pay for treatment (Cost-effectiveness)
within 3 weeks after surgery
Quality of life of patients EORTC QLQ-C30
within 3 weeks after surgery
- +2 more secondary outcomes
Study Arms (2)
patient blood management group
EXPERIMENTAL1. before surgery (within 2-6 weeks before surgery) \- 7 ≤ Hb \< 12 g/dL : ferric carboxymaltose 1000mg 2. during surgery \- In case of hemodynamically unstable, transfusion according to the judgment of the operating surgeon and anesthesiologist 3. after surgery (POD #1) * 7 ≤ Hb \< 12 g/dL : ferric carboxymaltose 1000mg * Hb \<7 g/dL : pRBC 2 packs transfusion
conventional management group
ACTIVE COMPARATOR1. before surgery (within 2-6 weeks before surgery) * 8 ≤ Hb \< 10 g/dL: pRBC 1 pack transfusion * Hb \< 8 g/dL: pRBC 2 packs transfusion \* Use of oral iron supplements, EPO, in control patients is permitted. (no IV iron supplements) 2. during surgery \- In case of hemodynamically unstable, transfusion according to the judgment of the operating surgeon and anesthesiologist 3. after surgery (POD #1) * 8 ≤ Hb \< 10 g/dL: pRBC 1 pack transfusion * Hb \< 8 g/dL: pRBC 2 packs transfusion \* Use of oral iron supplements, EPO, in control patients is permitted. (no IV iron supplements)
Interventions
ferric carboxymaltose 1000mg, fixed dose for intervention group
Eligibility Criteria
You may qualify if:
- Women aged 20-80 years
- Untreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer)
- Patients with ECOG performance status 0-2
- Patients with ASA PS 1-2
- Preoperative Hgb ≥ 7 g/dL
- Patients who are scheduled for preoperative iron panel test (serum ferritin, iron, TIBC)
- In case of showing proper organ function WBC ≥ 3,000/mm3 Platelets ≥ 100,000/mm3 Creatinine ≤ 2.0 mg/dL Bilirubin ≤ 1.5 x institutional upper limit normal SGOT, SGPT, and ALP ≤ 3 x institutional upper limit normal
- Patient who voluntarily signed the informed consent form
You may not qualify if:
- Patient who unable to determine whether or not to consent on their own
- Patients with serious underlying diseases or complications
- Women who are pregnant or lactating
- Patients with concurrent infection
- Patients who are allergic to existing iron preparations
- Patients who underwent neoadjuvant chemotherapy or preoperative radiation therapy
- Patients who have had or received cancer treatment within 5 years, except for non-melanoma skin cancer, cervical intraepithelial tumor, and superficial cancer of the stomach and bladder
- Patients with iron overload or iron utilization disorders
- Patients with serum ferritin \> 800ng/mL or TSAT \> 50% on Iron panel tests
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736, South Korea
Related Publications (1)
Park JY, Kang OJ, Lee YY, Kim YS. A prospective randomized controlled trial evaluating the safety and efficacy of patient blood management program in patients with gynecologic cancer (KGOG 4011/PBM). Int J Gynecol Cancer. 2023 Jul 3;33(7):1140-1144. doi: 10.1136/ijgc-2023-004403.
PMID: 37094968DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong-Yeol Park
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 29, 2022
First Posted
January 3, 2023
Study Start
February 1, 2023
Primary Completion
June 1, 2025
Study Completion
December 1, 2025
Last Updated
January 5, 2023
Record last verified: 2023-01