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

10. februar 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Forventet)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tilbagevirkende kraft

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the overall incidence of vaso-occlusive-events 1 month post surgery
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the incidence of Vaso Occlusive Crisis 1 month post surgery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 month after surgery
Number of RBC unit transfused
1 month after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Alina Ferster, MD, Queen Fabiola Children's University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2020

Primær færdiggørelse (Forventet)

31. maj 2020

Studieafslutning (Forventet)

30. juni 2020

Datoer for studieregistrering

Først indsendt

7. februar 2020

Først indsendt, der opfyldte QC-kriterier

10. februar 2020

Først opslået (Faktiske)

11. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. februar 2020

Sidst verificeret

1. januar 2020

Mere information

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