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NCT Number: NCT04343170

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

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

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Key information

Conditions

Ultra-short-term Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Scoliosis Idiopathic

Age range

13 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

tarek Abdel Lattif

Tanta, Egypt

About this study

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 α 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

Placebo

Drug

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

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)

Primary outcomes

  1. percentage of patients not required blood transfusion

    Time frame: up to 7 days postoperative

    percentage of patients not required blood transfusion

Secondary outcomes

  1. the length in I.C.U

    Time frame: during ICU stay period up to 7 days postoperative

    the length in I.C.U by days

  2. the incidence of acute kidney injury

    Time frame: up to 7 days postoperative

    number of patients developed acute kidney injury

  3. incidence of infections requiring antibiotic treatment

    Time frame: up to 7 days postoperative

    number of patients developed infections requiring antibiotic treatment

  4. perioperative hemoglobin

    Time frame: up to 7 days postoperative

    perioperative hemoglobin by gm

  5. perioperative platelet

    Time frame: up to 7 days postoperative

    perioperative platelet presented as platelet count per microliter of blood

  6. perioperative leucocyte counts

    Time frame: up to 7 days postoperative

    perioperative leucocyte counts presented as white blood cells per microliter

  7. calculated Red blood cells loss

    Time frame: up to 7 days postoperative

    calculated Red blood cells loss by ml

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2020
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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