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Study to check if giving iron through iv line to patients with low Hb arising due to low iron in the blood before joint replacement surgery decreases the need of giving blood during or after the surgery

Effect of pre-operative optimization of iron deficiency anemia in elective joint replacement patients on transfusion rates

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037850
Enrollment
200
Registered
2021-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: M160- Bilateral primary osteoarthritis of hip Health Condition 2: M170- Bilateral primary osteoarthritis of knee Health Condition 3: M161- Unilateral primary osteoarthritisof hip Health Condition 4: M171- Unilateral primary osteoarthritisof knee

Interventions

Intervention1: Ferric Carboxymaltose: Administration of iv iron (Ferric Carboxymaltose) to patients with iron deficiency anemia in patients undergoing joint replacement surgeries. Ferric Carboxymaltos
the company has no role in design, data-analysis and publication of the study. Intervention2: Ferric Carboxymaltose: Administration of iv iron (Ferric Carboxymaltose) to patients with iron deficiency
the company has no role in design, data-analysis and publication of the study. Dose: 1000mg Frequency and duration of therapy: One dose, 2 weeks before the surgery Route: Intra venous, 1000mg in 100m

Sponsors

Christian Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Elective primary hip and knee replacement with haemoglobin 10-12 g/dl in females and 10-13 in males with the cause being Iron deficiency anemia

Exclusion criteria

Exclusion criteria: Revision Arthroplasty, Primary Infection, Primary Neoplasm

Design outcomes

Primary

MeasureTime frame
To compare blood transfusion rates after surgery in patients who receives iron transfusion with historical controls Control: Population matching will be done in respect to Age, Sex, Hb/PCV level and the type of surgery done. Timepoint: 2 weeks

Secondary

MeasureTime frame
Secondary measures of blood loss like Hb drop, Per op blood loss and cost effectiveness of intervention, post op infection, Length of stay, final hospital bill.Timepoint: 2 weeks

Countries

India

Contacts

Public ContactLalmalsawmi Ralte

Department of Orthopaedics, Unit 3, CMCH, Vellore

Alfred_ortho@yahoo.com

Outcome results

None listed

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