- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04264871
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
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.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
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Brussles
-
Brussels, Brussles, 벨기에, 1020
- Hôpital Universitaire Des Enfants Reine Fabiola
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Sickle cell disease with surgery during the 2010-2019 period
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 회고전
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To assess the overall incidence of vaso-occlusive-events 1 month post surgery
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To assess the incidence of Vaso Occlusive Crisis 1 month post surgery
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 1 month after surgery
|
Number of RBC unit transfused
|
1 month after surgery
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Alina Ferster, MD, Queen Fabiola Children's University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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