A prospective randomized controlled trial evaluating the safety and efficacy of patient blood management program in patients with gynecologic cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008092

Enrollment

334

Registered

2023-01-09

Start date

2023-01-02

Completion date

Unknown

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Design: A prospective randomized controlled trial Treatment of patients for each carcinoma is carried out according to KSGO’s treatment guideline 1. PBM on Surgical treatment (1) before surger

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Transfusion rate within 3 weeks after surgery	—

Secondary

Measure	Time frame
Treatment related adverse events ;Comparison of hemoglobin differences between the groups;Frequency of anemia and blood transfusion before adjuvant therapy between the groups;Frequency and delay period of treatment delay due to anemia before adjuvant therapy between the groups;Differences in quality of life of between the groups;Cost-effectiveness differences of between the groups	—

Countries

Korea, Republic of

Contacts

Public ContactJEONG YEOL PARK

Asan Medical Center

catgut1-0@hanmail.net+82-2-3010-3646

Outcome results