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

NCT04264871 | Unknown

• 1 other identifier: P2020/Hemato/SCDPreop
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• To assess the overall incidence of vaso-occlusive-events 1 month post 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

Secondary Outcomes (11)

• To assess the incidence of Vaso Occlusive Crisis 1 month post surgery

  1 month after surgery

• To assess the incidence of Vaso Occlusive Crisis 3 months post surgery

  3 months after surgery

• To assess the incidence of Vaso Occlusive Crisis 12 months post surgery

  12 months after surgery

• To assess the incidence of Acute Chest Syndrome 1 month post surgery

  1 month after surgery

• To assess the incidence of Acute Chest Syndrome 3 months post surgery

  3 months after surgery

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Queen Fabiola Children's University Hospital: lead

Study Sites (1)

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, Brussles, 1020, Belgium

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Alina Ferster, MD

  Queen Fabiola Children's University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 11, 2020
• Study Start: January 1, 2020
• Primary Completion: May 31, 2020
• Study Completion: June 30, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-01

Locations

BE (1)