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

10 februari 2020 bijgewerkt door: Queen Fabiola Children's University Hospital

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Sikkelcelziekte

Studietype

Observationeel

Inschrijving (Verwacht)

250

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

België
- Brussles
  - Brussels, Brussles, België, 1020
    - Hôpital Universitaire Des Enfants Reine Fabiola

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients with sickle cell disease followed at Hôpital Universitaire des Enfants Reine Fabiola and having undergone a surgery betwee 2010-2019

Beschrijving

Inclusion Criteria:

Sickle cell disease with surgery during the 2010-2019 period

Exclusion Criteria:

None

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: Cohort
Tijdsperspectieven: Retrospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
To assess the overall incidence of vaso-occlusive-events 1 month post surgery Tijdsspanne: 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	1 month after surgery

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
To assess the incidence of Vaso Occlusive Crisis 1 month post surgery Tijdsspanne: 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)	1 month after surgery
To assess the incidence of Vaso Occlusive Crisis 3 months post surgery Tijdsspanne: 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)	3 months after surgery
To assess the incidence of Vaso Occlusive Crisis 12 months post surgery Tijdsspanne: 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)	12 months after surgery
To assess the incidence of Acute Chest Syndrome 1 month post surgery Tijdsspanne: 1 month after 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 Tijdsspanne: 3 months after 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 Tijdsspanne: 12 months after 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 Tijdsspanne: 1 month after 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 Tijdsspanne: 1 month after 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 Tijdsspanne: 3 months after 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 Tijdsspanne: 12 months after 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 Tijdsspanne: 1 month after surgery	Number of RBC unit transfused	1 month after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Queen Fabiola Children's University Hospital

Onderzoekers

Hoofdonderzoeker: Alina Ferster, MD, Queen Fabiola Children's University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2020

Primaire voltooiing (Verwacht)

31 mei 2020

Studie voltooiing (Verwacht)

30 juni 2020

Studieregistratiedata

Eerst ingediend

7 februari 2020

Eerst ingediend dat voldeed aan de QC-criteria

10 februari 2020

Eerst geplaatst (Werkelijk)

11 februari 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)