- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00726349
Transfusion Requirements in Orthopedic Surgery (PHASE 2) (TRIOS)
Transfusion Requirements in Orthopedic Surgery (Phase 2): A Prospective Observational Evaluation of the Optimal Transfusion Trigger.
The objective of our research program is to determine the transfusion threshold required to maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in these, most often, elderly patient with serious comorbidities.
Hypothesis: we hypothesize that a threshold hemoglobin concentration exists below which functional recovery becomes difficult, even if the vital prognosis of patients is not impaired.
연구 개요
상세 설명
Anemia is frequent after a surgical procedure. Postoperative anemia is associated with an increased incidence of transfusions and, probably, with an increased incidence of morbidity and mortality. However, the majority of studies evaluating the consequences of postoperative anemia are retrospective and, since anemic patients were transfused, they are unable to distinguish between the effects of anemia per se and those of transfusion. In orthopedic surgery, only two randomized controlled trials (RCT) have attempted to determine the benefits of transfusions in this patient population. The first evaluated the benefits of allogeneic transfusions in patients undergoing surgery for a fractured hip while the second evaluated autologous transfusions in patients undergoing total knee replacement. The small number of patients included in both studies did not allow definitive conclusions on the benefits (or lack thereof) of transfusions in orthopedic surgery.
Traditionally, a transfusion trigger of 100 g/L has been recommended in the postoperative period, especially in older patients and in those with serious comorbidities. In the Transfusion Requirements in Critical Care trial, a much lower transfusion threshold (70 g/L) was adopted in the group of patients in whom transfusions were restricted. This prospective randomized trial that included 838 patients, is, to this day, the most important in the field and generated unexpected results. Serious morbidity (cardiac and respiratory in particular) and mortality were not increased by the adoption of a low transfusion trigger while the number of transfusions was decreased significantly.
On the other hand, it is common to observe fatigue, decreased exercise capacity and muscle strength, and impaired performance of activities of daily life in the presence of anemia, especially when the hemoglobin concentration decreases below 90 - 100 g/L. In orthopedic surgery, a decrease in "postoperative vigor" can prevent patients from undertaking the rehabilitation program required to improve functional recovery after hip fracture repair.
The objective of our research program is to determine the transfusion threshold required to maximize functional recovery after major orthopedic surgery (total hip/knee replacement) in these, most often, elderly patient with serious comorbidities.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H2L 4M1
- CHUM-Hopital Notre-Dame
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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:
- Patients undergoing isolated elective total hip or knee arthroplasty (primary or revision surgery for a non-malignant condition), aged 60 years or older and able to walk prior to surgery.
Exclusion Criteria:
- Since this an observational study, all patients conforming to inclusion criteria will be included.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Observation
Patients undergoing isolated elective total hip or knee arthroplasty (primary or revision surgery for a non-malignant condition), aged 60 years or older and able to walk prior to surgery.
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Observational study.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Distance walked in 6 minutes after the operation. This is a simple, objective and reliable measure of functional recovery.
기간: 4 to 6 days after surgery
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4 to 6 days after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Fatigue, dizziness, difficulty to mobilize, difficulty/inability to participate in physiotherapy, prolonged hospital stay, major adverse events (especially cardiac, respiratory, neurological or infectious), death, impact of anemia on quality of life.
기간: up to 4-6 days after surgery
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up to 4-6 days after surgery
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Long-term functional status
기간: 12 months following surgery
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12 months following surgery
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Long-term quality of life
기간: 12 months following surgery
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12 months following surgery
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Long-term complications related to perioperative anemia
기간: 12 months following surgery
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Evidence of myocardial ischemia, respiratory tract infections or other majors infections
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12 months following surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jean-François Hardy, MD, FRCPC, Centre Hospitalier Université Montréal
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HD 06.084
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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