Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Iron Deficiency Anemia
- Scoliosis Idiopathic
- Ultra-short-term
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Other
Participation Requirements
- Age
- Between 13 years and 45 years
- Gender
- Both males and females
Description
44 Patients will be randomly classified into two equal groups each of 22 patients Group I: Patients of this group received Combination treatment consisted of a slow (30 min) intravenous infusion of 20 mg/kg ferric carboxymaltose (maximum of 1000 mg), 40 000 U subcutaneous ? erythropoietin,1 mg subcu...
44 Patients will be randomly classified into two equal groups each of 22 patients Group I: Patients of this group received Combination treatment consisted of a slow (30 min) intravenous infusion of 20 mg/kg ferric carboxymaltose (maximum of 1000 mg), 40 000 U subcutaneous ? erythropoietin,1 mg subcutaneous vitamin B12(, and 5 mg oral folic acid (acidum folicum) Group II: Patients of this group received placebo treatment consisted of two subcutaneous injections of 1 mL saline and an oral placebo. Either iron or placebo (0•9% saline) were given intravenously via a black infusion set from behind a screen to assure blinding of the patient by a person not involved in data capturing or data entering. Patient's vital signs will be monitored during and at least 15 min after drug application. Treatment will be given one day before the operation Measurements: Demographic data The number of RBC transfusions during the first 7 days. Perioperative course of Hb, (reticulocyte count, reticulocyte Hb content). The need of fresh frozen plasma units transfused in first 7 days The need of platelets units transfused in first 7 days Platelet count. Total leucocyte counts. International normalized ratio. Serum creatinine. C-reactive protein, Calculated RBC loss (preoperative RBC mass minus RBC mass at postoperative fifth day plus transfused RBC mass) Length of ICU stay. Incidence of acute kidney injury Infections requiring antibiotics
Tracking Information
- NCT #
- NCT04343170
- Collaborators
- Not Provided
- Investigators
- Not Provided