Trial · NCT03231085
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
NCT03231085, Not applicable, Completed, University Hospital, Montpellier
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT03231085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03231085
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT03231085
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 100 participants, actual
- Lead sponsor
- University Hospital, Montpellier
- Conditions
- Craniosynostosis
- Interventions
- Ferrous fumarate or ferrostrane
- First posted
- 2017-07-27
- Last updated
- 2024-12-30
- Other registries' IDs
- eudract:2016-005065-31
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | Compliance of oral iron treatment | At the end of oral iron treatment | Evaluated by visual analogic scale (0 the minimum to 10 the maximum) |
| Secondary | 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 |
| Secondary | Number of packed red blood cells transfused in perioperative phase and during 3 days following | Perioperative phase and during 3 days following surgery | |
| Secondary | Volume of packed red blood cells transfused | Perioperative phase and during 3 days following surgery | Volume in mL/kg |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03231085
GET https://conductscience.org/api/trials/v1/NCT03231085/registered