CraniosynostosisIRON KIDNCT03231085
Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child
A study testing Ferrous fumarate or ferrostrane in people with Craniosynostosis, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries in children and especially in the surgery of craniosynostosis. The bioavailability of oral iron is low and compliance with treatment is inconsistent. Read more about this study
- Who is it for?
- Ages 4 to 24 months
- Conditions the study is for
- Craniosynostosis
- What is being tested?
- Ferrous fumarate or ferrostrane
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Oct 2017to 3 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 4 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Craniosynostosis Surgery
- Age: between 4 and 24 months inclusive
- Weight: less than 12kg
- Hemoglobin: 10 g / dl ≤ Hb 14 ≤ g / dl
- Affiliated patients or beneficiaries of a Social Security scheme
- Signature of the consent of the patient's parents
Who cannot join
- Generalized infection
- Time for consultation of anesthesia with respect to the date of surgery greater than 5 weeks or less than 22 days.
- Initial biological assessment dating more than 3 months before the consultation of anesthesia
- Parents do not understand French
- BMI greater than 20 kg.m-2
- Contraindications to EPO
- Contraindications to ferric carboxymaltose and to ferrous fumarate
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital of Angers
Angers, 49100
University Hospital of Montpellier
Montpellier, 34295
About this study
Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries in children and especially in the surgery of craniosynostosis. The bioavailability of oral iron is low and compliance with treatment is inconsistent. The aim of this study is to evaluate whether the use of ferric carboxymaltose by injection, which has a much better bioavailability, would make it possible to increase the preoperative hemoglobin level more effectively and thus reduce the risk of perioperative blood transfusion .
Read the detailed description
Prospective study, randomized in two parallel groups (martial treatment versus venous injection) and stratified by center (Montpellier, Nice, Angers).
The number of subjects required is 100 patients, or 50 per group.
- Conditions
- Craniosynostosis
- Being tested
- Ferrous fumarate or ferrostrane
- Keywords
- Craniosynostosis, hemoglobin, iron peros, iron intravenous
- Medical subject headings
- Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous fumarate or ferrostraneDrug
Also called Intravenous ferric carboxymaltose.
Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.
| Study group | Role | What they receive |
|---|---|---|
| Ferrous fumarate or ferrostrane | Active comparator | The oral treatment should begin 21 days before surgery.
Recommended Dosage ferrous fumarate according to the SPC in force:
* 5 to 8 kg: 2 cd rases / d or 200mg of ferrous fumarate
* 8 to 10 kg: 3 cd rases / d or 300mg of ferrous fumarate
* 10 to 12kg: 4 cd rases / d or 400mg of ferrous fumarate
Ferrostrane ® (syrup) Laboratory TEOFARMA SRL Either 34mg of iron per teaspoon
Recommended dosage according to the SPC in force:
* Infant 5 to 8 kg (about 1 to 6 months): 2 teaspoons a day,
* Infant from 8 to 12 kg (about 6 to 30 months): 3 teaspoons a day. Receives: Drug: Ferrous fumarate or ferrostrane |
| Ferric carboxymaltose | Experimental | The single intravenous treatment the day of the inclusion. Dosage according to: 15mg / kg iron (to dilute in 3 ml / kg of Nacl 0.9% (SSI), to pass in 15 minutes. Receives: Drug: Ferrous fumarate or ferrostrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation from reference in hemoglobin rate at the day before surgery
Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one day before surgery)
Measured: Hemoglobin rate change from reference day (right before treatment) to one day before surgery (from 22 days to 5 weeks maximum)
Secondary outcomes (11)
Variation from reference in hemoglobin rate at the day before surgery depending on the reference iron status
Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one day before surgery) depending on the reference iron status
Measured: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Variation from reference in hemoglobin rate at the day before surgery depending on the inflammatory state of patient evaluated by CRP rate before treatment
Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one day before surgery) depending on the CRP rate before treatment
Measured: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Frequency of EPO treatment discontinuation at the end of 2nd injection
Number of patient stopping EPO injections at the end of 2nd injection
Measured: 15 days before surgery
Variation from reference in iron status at the day before surgery
Changes in iron status between reference day (right before the implementation of treatment) and preoperative iron status (one day before surgery)
Measured: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Occurrence of adverse events due to experimental treatments
Comparision of adverse event du to experimental treatments (ferric carboxymaltose versus ferrous fumarate)
Measured: from treatment administration to end of patient follow-up
Compliance of oral iron treatment
Evaluated by visual analogic scale (0 the minimum to 10 the maximum)
Measured: At the end of oral iron treatment
Rate of blood transfusion in perioperative phase and during 3 days following surgery
Number of transfused patients among all patients
Measured: Perioperative phase and during 3 days following surgery
Number of packed red blood cells transfused in perioperative phase and during 3 days following
Measured: Perioperative phase and during 3 days following surgery
Volume of packed red blood cells transfused
Volume in mL/kg
Measured: Perioperative phase and during 3 days following surgery
Total perioperative blood loss
Expressed in red blood cell mass
Measured: Perioperative phase and during 3 days following surgery
Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment
Measured: At the end of patient folllow-up (6 months after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start31 Oct 2017
- Primary completion11 Apr 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniosynostosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe PIRAT, MD, Principal investigator, Department d'Anesthésie reanimation Lapeyronie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231085
- Sponsor's protocol ID
- 9769
- Other IDs
- 2016-005065-31, 2016
- Acronym
- IRON KID
- Status last verified
- Dec 2024
- First submitted
- 27 Jun 2017
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child
- ClinicalTrials.gov ID
- NCT03231085
- Acronym / sponsor ID
- IRON KID / 9769
- Conditions
- Craniosynostosis
- Keywords
- Craniosynostosis, hemoglobin, iron peros, iron intravenous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 27 Jul 2017 (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.
Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries in children and especially in the surgery of craniosynostosis. The bioavailability of oral iron is low and compliance with treatment is inconsistent. The aim of this study is to evaluate whether the use of ferric carboxymaltose by injection, which has a much better bioavailability, would make it possible to increase the preoperative hemoglobin level more effectively and thus reduce the risk of perioperative blood transfusion .
Detailed description
Prospective study, randomized in two parallel groups (martial treatment versus venous injection) and stratified by center (Montpellier, Nice, Angers).
The number of subjects required is 100 patients, or 50 per group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous fumarate or ferrostrane | Active comparator | Drug: Ferrous fumarate or ferrostraneThe oral treatment should begin 21 days before surgery. Recommended Dosage ferrous fumarate according to the SPC in force: * 5 to 8 kg: 2 cd rases / d or 200mg of ferrous fumarate * 8 to 10 kg: 3 cd rases / d or 300mg of ferrous fumarate * 10 to 12kg: 4 cd rases / d or 400mg of ferrous fumarate Ferrostrane ® (syrup) Laboratory TEOFARMA SRL Either 34mg of iron per teaspoon Recommended dosage according to the SPC in force: * Infant 5 to 8 kg (about 1 to 6 months): 2 teaspoons a day, * Infant from 8 to 12 kg (about 6 to 30 months): 3 teaspoons a day. |
| Ferric carboxymaltose | Experimental | Drug: Ferrous fumarate or ferrostraneThe single intravenous treatment the day of the inclusion. Dosage according to: 15mg / kg iron (to dilute in 3 ml / kg of Nacl 0.9% (SSI), to pass in 15 minutes. |
Who may qualify
- Ages
- 4 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Craniosynostosis Surgery
- Age: between 4 and 24 months inclusive
- Weight: less than 12kg
- Hemoglobin: 10 g / dl ≤ Hb 14 ≤ g / dl
- Affiliated patients or beneficiaries of a Social Security scheme
Key exclusion criteria (7 listed)
- Generalized infection
- Time for consultation of anesthesia with respect to the date of surgery greater than 5 weeks or less than 22 days.
- Initial biological assessment dating more than 3 months before the consultation of anesthesia
- Parents do not understand French
- BMI greater than 20 kg.m-2
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 |
|---|---|---|
| Ferrous fumarate or ferrostraneAlso: Intravenous ferric carboxymaltose.Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose. | Drug | Ferric carboxymaltose, Ferrous fumarate or ferrostrane |
Primary outcome
Variation from reference in hemoglobin rate at the day before surgery
Time frame: Hemoglobin rate change from reference day (right before treatment) to one day before surgery (from 22 days to 5 weeks maximum)
Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one day before surgery)
11 secondary outcomes
Variation from reference in hemoglobin rate at the day before surgery depending on the reference iron status
Time frame: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Variation from reference in hemoglobin rate at the day before surgery depending on the inflammatory state of patient evaluated by CRP rate before treatment
Time frame: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Frequency of EPO treatment discontinuation at the end of 2nd injection
Time frame: 15 days before surgery
Variation from reference in iron status at the day before surgery
Time frame: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Occurrence of adverse events due to experimental treatments
Time frame: from treatment administration to end of patient follow-up
Compliance of oral iron treatment
Time frame: At the end of oral iron treatment
Rate of blood transfusion in perioperative phase and during 3 days following surgery
Time frame: Perioperative phase and during 3 days following surgery
Number of packed red blood cells transfused in perioperative phase and during 3 days following
Time frame: Perioperative phase and during 3 days following surgery
Volume of packed red blood cells transfused
Time frame: Perioperative phase and during 3 days following surgery
Total perioperative blood loss
Time frame: Perioperative phase and during 3 days following surgery
Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment
Time frame: At the end of patient folllow-up (6 months after surgery)
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 30 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Craniosynostosis
Not yet recruitingObservational study
Multimodal Mechanical, Tissue, Architectural, and Histological Evaluation of the Bone and Sutures of the Parietal Bone in an Infant With Craniosynostosis.
Craniostenosis
Active, not recruitingPhase 1
Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
Not yet recruiting
Frontal Reconstruction Without Orbital Advancement for Moderate Metopic Craniosynostosis
Metopic Craniosynostosis, Craniosynostosis
Not yet recruiting
Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
Premature Newborns, Cranial Asymmetry
RecruitingObservational study
Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
Metopic Synostosis
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.
Philippe PIRAT, MD principal investigator
Department d'Anesthésie reanimation Lapeyronie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous fumarate or ferrostrane in people with Craniosynostosis, run by University Hospital, Montpellier at 2 sites in France.
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 6 inclusion and 7 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 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. 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?
Variation from reference in hemoglobin rate at the day before surgery (time frame: Hemoglobin rate change from reference day (right before treatment) to one day before surgery (from 22 days to 5 weeks maximum)). 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 30 Dec 2024.