NCT04343170

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

Completed NA Last updated 16 April 2025

What this trial tests

NA trial testing Placebo in Ultra-short-term in 44 participants. Completed in 1 October 2024.

Timeline

1 September 2023

Primary endpoint
15 September 2024

1 October 2024

Quick facts

Lead sponsor	Tanta University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	44
Start date	1 September 2023
Primary completion	15 September 2024
Estimated completion	1 October 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Placebo
• ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acid — full drug profile →

Conditions studied

• Ultra-short-term — all drugs for Ultra-short-term →
• Iron Deficiency Anemia — all drugs for Iron Deficiency Anemia →
• Scoliosis Idiopathic — all drugs for Scoliosis Idiopathic →

Sponsor

Tanta University

Who can join

Adults 13 to 45, any sex, with Ultra-short-term or Iron Deficiency Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.