Intravenous Iron for Iron Deficiency in Scoliosis
(IV-KIDS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether administering iron through an IV (intravenous) before surgery can enhance recovery for young people undergoing spinal fusion surgery to correct scoliosis. Researchers aim to determine if ferric carboxymaltose IV can reduce the need for blood transfusions and improve mental and physical recovery post-surgery. The trial will compare the effects of the iron treatment to a placebo (a harmless substance resembling the real treatment) and include a group for observational follow-up. Suitable candidates for this trial are those aged 10-19 with scoliosis or kyphosis, scheduled for spinal fusion surgery soon, and with low iron levels. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that ferric carboxymaltose, an iron treatment administered through an IV, is generally safe and well-tolerated. Studies indicate that a single 1000 mg dose effectively treats iron deficiency anemia without causing serious side effects.
One study found that using this treatment in surgical patients with iron deficiency anemia post-surgery was both practical and safe. No major safety concerns were reported, indicating that most people tolerate the treatment well.
Overall, these findings suggest that ferric carboxymaltose is a safe option for treating iron deficiency, especially in situations where patients might lose significant blood, such as during surgery.12345Why do researchers think this study treatment might be promising for scoliosis?
Unlike the standard oral iron supplements typically used for iron deficiency in scoliosis patients, ferric carboxymaltose is administered intravenously, allowing for quicker and more efficient absorption. This method bypasses the digestive system, which can minimize gastrointestinal side effects commonly associated with oral iron. Researchers are excited because this could mean faster iron level improvement, especially crucial for patients undergoing surgery, helping them recover better and faster.
What evidence suggests that intravenous ferric carboxymaltose might be an effective treatment for iron deficiency in scoliosis?
Research shows that intravenous ferric carboxymaltose, which participants in this trial may receive, effectively increases iron levels in patients undergoing surgery. Studies have found that this treatment raises hemoglobin (the protein in red blood cells that carries oxygen), serum ferritin (a protein that stores iron), and transferrin saturation (a measure of iron in the blood). Improved iron levels can reduce the need for blood transfusions during surgery, which is especially important for teenagers with scoliosis undergoing surgery. Data from multiple studies suggest that intravenous iron outperforms oral iron supplements in improving these critical blood measures. This indicates that ferric carboxymaltose may help manage iron deficiency and enhance surgical outcomes.16789
Are You a Good Fit for This Trial?
This trial is for adolescents and young adults who are preparing for spinal fusion surgery to correct scoliosis or other spinal deformities. They must be at risk of iron deficiency and anemia but cannot have conditions that would exclude them from safely receiving intravenous iron.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Treatment
Participants receive a one-time preoperative dose of IV ferric carboxymaltose or placebo on the morning of surgery
Surgery and Immediate Postoperative Care
Participants undergo spinal fusion surgery and receive perioperative care, including monitoring for RBC transfusion
Follow-up
Participants are monitored for changes in neurocognitive function and physical capacity postoperatively
What Are the Treatments Tested in This Trial?
Interventions
- Ferric carboxymaltose IV
Trial Overview
The study tests if giving Ferric carboxymaltose (a type of IV iron) before surgery can reduce the need for blood transfusions and improve recovery compared to a saline placebo. Participants will be randomly assigned to receive either the iron treatment or placebo.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Participants will receive ferric carboxymaltose, 15mg/kg up to 750mg intravenously, on the morning of surgery.
Participants who do not qualify for randomization may be invited to complete study measures through postoperative follow-up as part of an observational study.
Patients will receive normal saline, intravenously, on the morning of surgery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Association for the Advancement of Blood & Biotherapies
Collaborator
Citations
IntraVenous Iron in Kids With Iron Deficiency and Scoliosis ...
Adolescents undergoing spinal fusion surgery for scoliosis and/or kyphosis are poised to benefit from preoperative iron supplementation. Spinal ...
IntraVenous Iron in Kids With Iron Deficiency and Scoliosis ...
Adolescents undergoing spinal fusion surgery for scoliosis and/or kyphosis are poised to benefit from preoperative iron supplementation. Spinal fusion carries a ...
3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT04343170?term=AREA%5BConditionSearch%5D(%22Iron%20Deficiency%20Anemia%22)%20AND%20AREA%5BInterventionSearch%5D(%22Vitamin%20B12%22)&rank=7Effect of Ultra-short-term Treatment of Patients With Iron ...
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 ...
(PDF) Effect Of Ultra-Short-Term Treatment of Patients with ...
Objectives The study aimed to evaluate the response of patients with iron deficiency or anemia undergoing adolescent scoliosis correction to ultra-short-term ...
Meta-analysis of efficacy and safety of intravenous ferric ...
Intravenous ferric carboxymaltose improved mean Hb, serum ferritin, and transferrin saturation levels; the mean end-of-trial increase over oral ...
Efficacy, Safety, and Tolerability of Ferric Carboxymaltose ...
This study comprehensively compares the efficacy, safety, and tolerability of two commonly used intravenous iron preparations, ferric carboxymaltose (FCM) and ...
Intravenous ferric carboxymaltose versus standard care in ...
Postoperative intravenous ferric carboxymaltose is a feasible and pragmatic management approach in surgical patients with functional iron deficiency anaemia.
Effects of ferric derisomaltose on postoperative anaemia in ...
Ferric derisomaltose is a third-generation intravenous iron supplement that has been demonstrated to be effective and safe in treating iron-deficiency anaemia ...
9.
bmcwomenshealth.biomedcentral.com
bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-017-0506-8Effectiveness and safety of ferric carboxymaltose compared to ...
This study in conclusion demonstrates that a single dose of 1000 mg IV FCM infusion is safe and effective in the treatment of IDA in women. FCM ...
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