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

• Conditions: Sickle Cell Disease

• Registration Number: NCT04264871
• Lead Sponsor: Queen Fabiola Children's University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01-01
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-11
• Primary Completion: 2020-05-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the overall incidence of vaso-occlusive-events 1 month post surgery	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

Secondary Outcome Measures

Name	Time	Method
To assess the number of RBC transfusion episodes 1 month post surgery	1 month after surgery	Number of RBC unit transfused
To assess the incidence of Acute Chest Syndrome 12 months post surgery	12 months after surgery	Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever
To assess the incidence of Red Blood Cell (RBC) allo-immunization 1 month post surgery	1 month after surgery	incidence of acute anemia with the presence of new allo-antibody(ies) against RBC
To assess the incidence of RBC allo-immunization 12 months post surgery	12 months after surgery	incidence of acute anemia with the presence of new allo-antibody(ies) against RBC
To assess the incidence of Vaso Occlusive Crisis 12 months post surgery	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)
To assess the incidence of Vaso Occlusive Crisis 3 months post surgery	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)
To assess the incidence of Acute Chest Syndrome 1 month post surgery	1 month after surgery	Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever
To assess the incidence of RBC allo-immunization 3 months post surgery	3 months after surgery	incidence of acute anemia with the presence of new allo-antibody(ies) against RBC
To assess the incidence of Acute Chest Syndrome 3 months post surgery	3 months after surgery	Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever
To assess the duration of hospitalization post-surgery	1 month after surgery	number of days between surgery and day of discharge
To assess the incidence of Vaso Occlusive Crisis 1 month post surgery	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)

Trial Locations

Locations (1)

Hôpital Universitaire Des Enfants Reine Fabiola; 🇧🇪 Brussels, Brussles, Belgium