Clinical trial · Interventional
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
NCT05669872CI-TRIAL-00063022unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferric Carboxymaltose 50Mg/Ml Inj 20Ml | Drug | — | UNRESOLVED |
| RBC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- patient blood management group
- description
- 1. 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
- interventionNames
- Drug: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml
- type
- ACTIVE_COMPARATOR
- label
- conventional management group
- description
- 1. 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)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 20-80 years 2. Untreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer) 3. Patients with ECOG performance status 0-2 4. Patients with ASA PS 1-2 5. Preoperative Hgb ≥ 7 g/dL 6. Patients who are scheduled for preoperative iron panel test (serum ferritin, iron, TIBC) 7. 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 8. Patient who voluntarily signed the informed consent form Exclusion Criteria: 1. Patient who unable to determine whether or not to consent on their own 2. Patients with serious underlying diseases or complications 3. Women who are pregnant or lactating 4. Patients with concurrent infection 5. Patients who are allergic to existing iron preparations 6. Patients who underwent neoadjuvant chemotherapy or preoperative radiation therapy 7. 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 8. Patients with iron overload or iron utilization disorders 9. Patients with serum ferritin \> 800ng/mL or TSAT \> 50% on Iron panel tests
References
Publications (1)
- DERIVEDPark 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 37094968