Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

10. februar 2020 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Studietype

Observasjonsmessig

Registrering (Forventet)

250

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Brussles
      • Brussels, Brussles, Belgia, 1020
        • Hôpital Universitaire Des Enfants Reine Fabiola

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Retrospektiv

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2020

Primær fullføring (Forventet)

31. mai 2020

Studiet fullført (Forventet)

30. juni 2020

Datoer for studieregistrering

Først innsendt

7. februar 2020

Først innsendt som oppfylte QC-kriteriene

10. februar 2020

Først lagt ut (Faktiske)

11. februar 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. februar 2020

Sist bekreftet

1. januar 2020

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere