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

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.

Study Overview

• Status: Unknown
• Conditions: Sickle Cell Disease

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Belgium
  • Brussles
    • Brussels, Brussles, Belgium, 1020
      • Hôpital Universitaire des Enfants Reine Fabiola

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the incidence of Vaso Occlusive Crisis 1 month post 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	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	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	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	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	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	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	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	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	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	Number of RBC unit transfused	1 month after surgery

Collaborators and Investigators

• Sponsor: Queen Fabiola Children's University Hospital
• Investigators: Principal Investigator: Alina Ferster, MD, Queen Fabiola Children's University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Postoperative Complications
• Other Study ID Numbers: P2020/Hemato/SCDPreop

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No