Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-005065-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
Ferrostrane ® (syrup) Laboratory TEOFARMA SRL Either 34mg of iron per teaspoon Recommended dosage according to the SPC in force:
|
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous fumarate or ferrostrane | Drug | Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Hemoglobin rate change from reference day (right before treatment) to one day before surgery (from 22 days to 5 weeks maximum) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philippe PIRAT, MD | Department d'Anesthésie reanimation Lapeyronie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Angers | Angers | 49100 | France | |||
| University Hospital of Montpellier |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 | 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 | 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) | 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) | 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) | 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 | Perioperative phase and during 3 days following surgery |
| 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 | Volume in mL/kg | Perioperative phase and during 3 days following surgery |
| Total perioperative blood loss | Expressed in red blood cell mass | Perioperative phase and during 3 days following surgery |
| Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment | At the end of patient folllow-up (6 months after surgery) |
| Montpellier |
| 34295 |
| France |
| ID | Term |
|---|---|
| D003398 | Craniosynostoses |
| ID | Term |
|---|---|
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C031621 | ferrous fumarate |
| C019179 | Fe(III)-EDTA |
Not provided
Not provided
Not provided