| Registry | NCT03231085, acronym IRON KID |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 100 (Actual) |
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| Sponsor | University Hospital, Montpellier (Other) |
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| Conditions | Craniosynostosis |
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| Interventions | Ferrous fumarate or ferrostrane (Drug) |
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| Dates | start 2017-10-31, primary completion 2024-04-11, completion 2024-10-03, first posted 2017-07-27, last updated 2024-12-30 |
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| Locations | 2 sites in France |
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All trials for Craniosynostosis All trials of Ferrous fumarate or ferrostrane
-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. 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 .
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Ferrous fumarate or ferrostrane | Active comparator | Drug: Ferrous fumarate or ferrostrane | 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. |
| Ferric carboxymaltose | Experimental | 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. |
- Ferrous fumarate or ferrostrane (Drug), also known as Intravenous ferric carboxymaltose.: Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.
+Outcome measures
Primary outcomes
- Variation from reference in hemoglobin rate at the day before surgery [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)
Secondary outcomes
- Variation from reference in hemoglobin rate at the day before surgery depending on the reference iron status [Reference day (right before treatment) and 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) depending on the reference iron status
- Variation from reference in hemoglobin rate at the day before surgery depending on the inflammatory state of patient evaluated by CRP rate before treatment [Reference day (right before treatment) and 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) depending on the CRP rate before treatment
- Frequency of EPO treatment discontinuation at the end of 2nd injection [15 days before surgery]: Number of patient stopping EPO injections at the end of 2nd injection
- Variation from reference in iron status at the day before surgery [Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)]: Changes in iron status between reference day (right before the implementation of treatment) and preoperative iron status (one day before surgery)
- Occurrence of adverse events due to experimental treatments [from treatment administration to end of patient follow-up]: Comparision of adverse event du to experimental treatments (ferric carboxymaltose versus ferrous fumarate)
- Compliance of oral iron treatment [At the end of oral iron treatment]: Evaluated by visual analogic scale (0 the minimum to 10 the maximum)
- Rate of blood transfusion in perioperative phase and during 3 days following surgery [Perioperative phase and during 3 days following surgery]: Number of transfused patients among all patients
- Number of packed red blood cells transfused in perioperative phase and during 3 days following [Perioperative phase and during 3 days following surgery]
- Volume of packed red blood cells transfused [Perioperative phase and during 3 days following surgery]: Volume in mL/kg
- Total perioperative blood loss [Perioperative phase and during 3 days following surgery]: Expressed in red blood cell mass
- Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment [At the end of patient folllow-up (6 months after surgery)]
+Eligibility
Sex: All, ages: 4 Months to 24 Months
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
+Locations (2)
| Facility | City | Country | Status |
|---|
| University Hospital of Angers | Angers | France | |
| University Hospital of Montpellier | Montpellier | France | |
+Investigators
- Philippe PIRAT, MD, Principal investigator, Department d'Anesthésie reanimation Lapeyronie
+Funding