Ultra-short-termNCT04343170
Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction
A study testing ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acid in people with Ultra-short-term and Iron Deficiency Anemia, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 45 years
- Conditions the study is for
- Ultra-short-term, Iron Deficiency Anemia, Scoliosis Idiopathic
- What is being tested?
- ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the detailed 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 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
- Being tested
- Placebo, ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acid
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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 acidDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Patients of this group received placebo treatment consisted of two subcutaneous injections of 1 mL saline and an oral placebo. Receives: 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) Receives: Drug: ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients not required blood transfusion
percentage of patients not required blood transfusion
Measured: up to 7 days postoperative
Secondary outcomes (7)
the length in I.C.U
the length in I.C.U by days
Measured: during ICU stay period up to 7 days postoperative
the incidence of acute kidney injury
number of patients developed acute kidney injury
Measured: up to 7 days postoperative
incidence of infections requiring antibiotic treatment
number of patients developed infections requiring antibiotic treatment
Measured: up to 7 days postoperative
perioperative hemoglobin
perioperative hemoglobin by gm
Measured: up to 7 days postoperative
perioperative platelet
perioperative platelet presented as platelet count per microliter of blood
Measured: up to 7 days postoperative
perioperative leucocyte counts
perioperative leucocyte counts presented as white blood cells per microliter
Measured: up to 7 days postoperative
calculated Red blood cells loss
calculated Red blood cells loss by ml
Measured: up to 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Sep 2023
- Primary completion15 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultra-short-termStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Faheem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343170
- Sponsor's protocol ID
- ultrashort treatment of anemia
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2020
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultra-short-term Treatment of Patients With Iron Deficiency or Anemia Undergoing Adolescent Scoliosis Correction
- ClinicalTrials.gov ID
- NCT04343170
- Acronym / sponsor ID
- ultrashort treatment of anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: PlaceboPatients of this group received placebo treatment consisted of two subcutaneous injections of 1 mL saline and an oral placebo. |
| ultra-short-term treatment | Experimental | Drug: ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acidPatients 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) |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPatients of this group received placebo treatment consisted of two subcutaneous injections of 1 mL saline and an oral placebo | Drug | control group |
| ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acidPatients 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 | ultra-short-term treatment |
Primary outcome
percentage of patients not required blood transfusion
Time frame: up to 7 days postoperative
percentage of patients not required blood transfusion
7 secondary outcomes
the length in I.C.U
Time frame: during ICU stay period up to 7 days postoperative
the incidence of acute kidney injury
Time frame: up to 7 days postoperative
incidence of infections requiring antibiotic treatment
Time frame: up to 7 days postoperative
perioperative hemoglobin
Time frame: up to 7 days postoperative
perioperative platelet
Time frame: up to 7 days postoperative
perioperative leucocyte counts
Time frame: up to 7 days postoperative
calculated Red blood cells loss
Time frame: up to 7 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acid in people with Ultra-short-term and Iron Deficiency Anemia, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients not required blood transfusion (time frame: up to 7 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.