Clinical trial NCT04264871: Is the Preoperative Preparation of Sickle Cell Patients Optimal: Assessment of Practices and Post-operative Complications
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sickle Cell Disease
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 250
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sickle cell disease followed at Hôpital Universitaire des Enfants Reine Fabiola and having undergone a surgery betwee 2010-2019

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Sickle cell disease with surgery during the 2010-2019 period

Exclusion Criteria:

* None

Primary outcomes:
measure: To assess the overall incidence of vaso-occlusive-events 1 month post surgery
timeFrame: 1 month after surgery
Secondary outcomes:
measure: To assess the incidence of Vaso Occlusive Crisis 1 month post surgery
timeFrame: 1 month after surgery
measure: To assess the incidence of Vaso Occlusive Crisis 3 months post surgery
timeFrame: 3 months after surgery
measure: To assess the incidence of Vaso Occlusive Crisis 12 months post surgery
timeFrame: 12 months after surgery
measure: To assess the incidence of Acute Chest Syndrome 1 month post surgery
timeFrame: 1 month after surgery
measure: To assess the incidence of Acute Chest Syndrome 3 months post surgery
timeFrame: 3 months after surgery
measure: To assess the incidence of Acute Chest Syndrome 12 months post surgery
timeFrame: 12 months after surgery
measure: To assess the duration of hospitalization post-surgery
timeFrame: 1 month after surgery
measure: To assess the incidence of Red Blood Cell (RBC) allo-immunization 1 month post surgery
timeFrame: 1 month after surgery
measure: To assess the incidence of RBC allo-immunization 3 months post surgery
timeFrame: 3 months after surgery
measure: To assess the incidence of RBC allo-immunization 12 months post surgery
timeFrame: 12 months after surgery
measure: To assess the number of RBC transfusion episodes 1 month post surgery
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire Des Enfants Reine Fabiola
state: Brussles
Study officials:
affiliation: Queen Fabiola Children's University Hospital
name: Alina Ferster, MD
role: PRINCIPAL_INVESTIGATOR
References: