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Trial record 4 of 33 for:    Craniosynostosis

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 (IRON KID)

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ClinicalTrials.gov Identifier: NCT03231085
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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 .

Condition or disease Intervention/treatment Phase
Craniosynostosis Drug: Ferrous fumarate Not Applicable

Detailed Description:

Prospective study, randomized in two parallel groups (martial treatment versus venous injection) and stratified by center (Montpellier, Nice).

The number of subjects required is 50 patients, or 25 per group.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : October 31, 2017
Actual Primary Completion Date : October 31, 2017
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Active Comparator: Fumafer

The oral treatment should begin 21 days before surgery.

Recommended Dosage 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
Drug: Ferrous fumarate
Young children operated with craniosynostosis and treated with EPO and ferrous fumarate per os or intravenous ferric carboxymaltose.
Other Name: Intravenous ferric carboxymaltose.

Experimental: Ferinject
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
Young children operated with craniosynostosis and treated with EPO and ferrous fumarate per os or intravenous ferric carboxymaltose.
Other Name: Intravenous ferric carboxymaltose.




Primary Outcome Measures :
  1. Preoperative hemoglobin [ Time Frame: day before surgery ]
    Preoperative hemoglobin


Secondary Outcome Measures :
  1. The number of patients transfused [ Time Frame: within 3 days post operative ]
    The number of patients transfused and the quantity in ml / kg of transfused



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Ages Eligible for Study:   4 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231085


Contacts
Contact: Philippe PIRAT, MD 0467338256 p-pirat@chu-montpellier.fr

Locations
France
University Hospital Recruiting
Montpellier, France, 34295
Contact: Sophie Bringuier, PharmaD    0467338256    s-bringuierbranchereau@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Philippe PIRAT, MD Department d'Anesthésie reanimation Lapeyronie

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03231085     History of Changes
Other Study ID Numbers: 9769
2016-005065-31 ( EudraCT Number )
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Craniosynostosis
hemoglobin
iron peros
iron intravenous

Additional relevant MeSH terms:
Craniosynostoses
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities
Epoetin Alfa
Ferrous fumarate
Hematinics
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs