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

Sickle Cell Disease Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04264871
• Other study ID #: P2020/Hemato/SCDPreop
• Status: Enrolling by invitation
• Start date: January 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2020
• Source: Queen Fabiola Children's University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: June 30, 2020
• Est. primary completion date: May 31, 2020
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Postoperative Complications
• Sickle Cell Disease

Locations

Country	Name	City	State
Belgium	Hôpital Universitaire Des Enfants Reine Fabiola	Brussels	Brussles

Sponsors (1)

Lead Sponsor	Collaborator
Queen Fabiola Children's University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	To assess the duration of hospitalization post-surgery	number of days between surgery and day of discharge	1 month after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	To assess the number of RBC transfusion episodes 1 month post surgery	Number of RBC unit transfused	1 month after surgery