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Is the Preoperative Preparation of Sickle Cell Patients Optimal: Assessment of Practices and Post-operative Complications

10 février 2020 mis à jour par: Queen Fabiola Children's University Hospital

Is the Preoperative Preparation of Sickle Cell Patients Optimal: Retrospective Assessment of Practices and Post-operative Complications in a Cohort of Children Followed at Hôpital Universitaire Des Enfants Reine Fabiola (HUDERF) and Who Have Been Managed According Local Guidelines Including Transfusion or Exchange Transfusion Before Surgery

Children with sickle cell disease systematically receive a transfusion 2 to 5 days before scheduled surgery (with the exception of minor surgeries) in order to avoid post-operative complications of which the vaso-occlusive crisis and acute thoracic syndrome are the most frequent.

This standardized preoperative protocol was established on the basis of the results of large-scale randomized studies, most of which date back over ten years, and which have demonstrated the beneficial effects of transfusion (or transfusion exchange) preoperatively. To date, several other more recent studies (but not controlled) have questioned this type of systematic management.

The purpose of this study is to review retrospectively data of sickle cell children who have undergone elective surgery at the Huderf in the last ten years and to identify the eventual complications encountered. The most common procedures in these patients are: tonsillectomy with or without associated adenoids, splenectomy and cholecystectomy.

General data on sickle cell disease (history, genotype, G6PD deficiency, biology and previous complications), pre-surgical preparation, surgery and post surgical management and complications will be collected and analyzed.

This retrospective analysis will allow an objective assessment of the current quality of care and will provide useful data to improve patient management.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Drépanocytose

Type d'étude

Observationnel

Inscription (Anticipé)

250

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Belgique
- Brussles
  - Brussels, Brussles, Belgique, 1020
    - Hôpital Universitaire Des Enfants Reine Fabiola

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Pas plus vieux que 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients with sickle cell disease followed at Hôpital Universitaire des Enfants Reine Fabiola and having undergone a surgery betwee 2010-2019

La description

Inclusion Criteria:

Sickle cell disease with surgery during the 2010-2019 period

Exclusion Criteria:

None

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: Cohorte
Perspectives temporelles: Rétrospective

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
To assess the overall incidence of vaso-occlusive-events 1 month post surgery Délai: 1 month after surgery	Vaso-occlusive-events will include Vaso Occlusive Crisis (acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)), acute chest syndrome (new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever) and hemoglobin < 6g/dl	1 month after surgery

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
To assess the incidence of Vaso Occlusive Crisis 1 month post surgery Délai: 1 month after surgery	Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)	1 month after surgery
To assess the incidence of Vaso Occlusive Crisis 3 months post surgery Délai: 3 months after surgery	Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)	3 months after surgery
To assess the incidence of Vaso Occlusive Crisis 12 months post surgery Délai: 12 months after surgery	Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)	12 months after surgery
To assess the incidence of Acute Chest Syndrome 1 month post surgery Délai: 1 month after surgery	Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever	1 month after surgery
To assess the incidence of Acute Chest Syndrome 3 months post surgery Délai: 3 months after surgery	Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever	3 months after surgery
To assess the incidence of Acute Chest Syndrome 12 months post surgery Délai: 12 months after surgery	Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever	12 months after surgery
To assess the duration of hospitalization post-surgery Délai: 1 month after surgery	number of days between surgery and day of discharge	1 month after surgery
To assess the incidence of Red Blood Cell (RBC) allo-immunization 1 month post surgery Délai: 1 month after surgery	incidence of acute anemia with the presence of new allo-antibody(ies) against RBC	1 month after surgery
To assess the incidence of RBC allo-immunization 3 months post surgery Délai: 3 months after surgery	incidence of acute anemia with the presence of new allo-antibody(ies) against RBC	3 months after surgery
To assess the incidence of RBC allo-immunization 12 months post surgery Délai: 12 months after surgery	incidence of acute anemia with the presence of new allo-antibody(ies) against RBC	12 months after surgery
To assess the number of RBC transfusion episodes 1 month post surgery Délai: 1 month after surgery	Number of RBC unit transfused	1 month after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Queen Fabiola Children's University Hospital

Les enquêteurs

Chercheur principal: Alina Ferster, MD, Queen Fabiola Children's University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2020

Achèvement primaire (Anticipé)

31 mai 2020

Achèvement de l'étude (Anticipé)

30 juin 2020

Dates d'inscription aux études

Première soumission

7 février 2020

Première soumission répondant aux critères de contrôle qualité

10 février 2020

Première publication (Réel)

11 février 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)