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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04264871

Enrollment

250

Registered

2020-02-11

Start date

2020-01-01

Completion date

2020-06-30

Last updated

2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Belgium

Outcome results