An interventional study of Ferrous fumarate or ferrostrane in Craniosynostosis, sponsored by University Hospital, Montpellier. Completed at 2 sites in France. Open to participants aged 4 Months to 24 Months. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Treatment
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 .
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.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's enrollment of 100 is above the median of 27 across 22 interventional studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Ferrous fumarate or ferrostrane
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.
Drug: Ferrous fumarate or ferrostrane
Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.
Also known as: Intravenous ferric carboxymaltose.
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)
Time frame: Hemoglobin rate change from reference day (right before treatment) to 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 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
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
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
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
Number of patient stopping EPO injections at the end of 2nd injection
Time frame: 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)
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
Comparision of adverse event du to experimental treatments (ferric carboxymaltose versus ferrous fumarate)
Time frame: 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)
Time frame: 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
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
Volume in mL/kg
Time frame: Perioperative phase and during 3 days following surgery
Total perioperative blood loss
Expressed in red blood cell mass
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)
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Apr 2024, 77 months.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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