Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction

NCT04343170 | Completed

• 1 other identifier: ultrashort treatment of anemia
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Scoliosis is a condition in which there is curvature of the spine occurring in the lateral plane. It occurs in structural forms, characterized by a fixed curve, and "functional" forms, characterized by a flexible or correctable curve. By anatomic necessity, this lateral deviation is associated with vertebral rotation, such that when this deformity occurs in the thoracic spine, a chest wall deformity, or "rib hump," develops. Often there is a primary structural curve with an adjacent secondary compensatory curve. Most cases of structural scoliosis are idiopathic and have their onset in early adolescence. Females are affected more often than males, and their curvature is more likely to worsen. Lumbar fusion surgery is usually associated with massive blood loss. In clinical practice the surgeon might measure the visible peri-operative bleeding including intra- and post-operative drainage, but ignore blood component penetration into the tissues, residual blood in vertebral canal and loss due to haemolysis, which are also known as hidden blood loss. In patients with adolescent idiopathic scoliosis (AIS), surgical treatment involves a posterior approach with multi-segmental pedicle screw fixation. Although this procedure is generally considered safe with few surgical complications, there are considerable variations in fusion length, surgical time, and the extent of soft-tissue exposure. Consequently, perioperative blood loss can be substantial, and the use of intraoperative and postoperative RBC transfusions are frequently required. Patient blood management (PBM) is an evidence-based, multidisciplinary approach developed over the last 10 years focusing on improving patient outcomes as well as reducing the use of RBC transfusions. PBM includes several preventive measures to manage bleeding risks, reduce iatrogenic blood loss, and modify decision thresholds for the appropriate administration of blood therapy. All patients for elective surgery in whom blood loss is expected to be \> 500 ml should have their hemoglobin checked pre-operatively and be investigated if they are found to be anemic. In the general population, anemia is defined as a hemoglobin less than 130 g. in men and less than 120g. in women by the WHO. It was proposed that the cut-off value/trigger be changed to hemoglobin more than 130 g for both men and women. Women with hemoglobin levels between 120 and 129 g. are not considered to be anemic according to the WHO definition, leaving them at a potential disadvantage when undergoing major surgery

Conditions

Ultra-short-term; Iron Deficiency Anemia; Scoliosis Idiopathic

Outcome Measures

Primary Outcomes (1)

• percentage of patients not required blood transfusion

  percentage of patients not required blood transfusion

  up to 7 days postoperative

Secondary Outcomes (7)

• the length in I.C.U

  during ICU stay period up to 7 days postoperative

• the incidence of acute kidney injury

  up to 7 days postoperative

• incidence of infections requiring antibiotic treatment

  up to 7 days postoperative

• perioperative hemoglobin

  up to 7 days postoperative

• perioperative platelet

  up to 7 days postoperative

Study Arms (2)

control group

PLACEBO COMPARATOR

Patients of this group received placebo treatment consisted of two subcutaneous injections of 1 mL saline and an oral placebo.

Drug: Placebo

ultra-short-term treatment

EXPERIMENTAL

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 α erythropoietin,1 mg subcutaneous vitamin B12(, and 5 mg oral folic acid (acidum folicum)

Drug: ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acid

Interventions

Placebo DRUG

Patients of this group received placebo treatment consisted of two subcutaneous injections of 1 mL saline and an oral placebo

control group

ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acid DRUG

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 α erythropoietin,1 mg subcutaneous vitamin B12(, and 5 mg oral folic acid (acidum folicum)

ultra-short-term treatment

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients with idiopathic adolescent scoliosis
• patients with anemia (haemoglobin concentration (Hb) \<12g/dL in women and Hb \<13 g/dL in men)
• patients with isolated iron deficiency (ferritin \<100 mcg/L, no anemia)

You may not qualify if:

• Impairments, diseases (renal \&/ hepatic) or language problems which do not allow the patient to fully understand the consequences of study participation
• Known allergy against iron - carboxymaltose
• Hemoglobin concentration (Hb) \<90 g/L in both male and female)

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

tarek Abdel Lattif

Tanta, Egypt

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Vitamin B 12; Folic Acid

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 13, 2020
• Study Start: September 1, 2023
• Primary Completion: September 15, 2024
• Study Completion: October 1, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)