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Effectiveness of single iron injection before gynaecological cancer surgery

Parenteral Iron Transfusion- Single Transfusion Program in Gynaecological cancer patients planned for curative surgery - PIT STOP

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095957
Enrollment
182
Registered
2025-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: C51-C58- Malignant neoplasms of female genital organs

Interventions

Intervention1: Ferric carboxymaltose injection: it is single dose of parenteral intravenous ferric carboxy maltose 15 mg/kg is given in 250 ml normal saline over 15 minutes Control Intervention1: conv

Sponsors

AAZPIRE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with gynaecological cancer scheduled for curative surgery.Age between 18-70 years.Screening Preoperative hemoglobin level between 8 gm/dL and 12 gm/dL.Iron profiling study diagnostic of iron deficiency anemia.Eastern Cooperative Oncology Group Score 0-1.Normal renal function tests and liver function test.Written informed consent

Exclusion criteria

Exclusion criteria: Known hypersensitivity or allergy to parenteral iron injections.HO of bleeding disorders, coagulopathy or thromboembolic events.HO of myocardial infarction within last one year or unstable angina or severe coronary disease.Administration of iron supplementation or blood transfusion within the last 3 months of date of enrollment.Ho Thalassemia and Vitamin B12 deficiency.hb less than 8 and greter than 12

Design outcomes

Primary

MeasureTime frame
The number of RBC transfusions between day of OPD registration to post operative day 28Timepoint: Initial day of OPD registration to post operation day 28

Secondary

MeasureTime frame
cbc levelTimepoint: preop day, post op day 1 , post op day 28;adverse eventsTimepoint: within 2 hours of transfusion

Countries

India

Contacts

Public ContactKarthik Chandra Bassetty

Dr. Bhubaneswar Borooah Cancer Institute

kcbassetty@gmail.com7896492093

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026