빠른 혈전증 검출을위한 체계적인 기계 학습 알고리즘 (DVT-SMART)
Point of Care D-Dimer, AI 기반 예측 모델 및 압축 초음파로 구성된 의심되는 DVT에 대한 새로운 진단 전략 평가
The goal of this clinical trial is to compare the use of a machine learning-based algorithm and point-of-care D-dimer to laboratory D-dimer and compression ultrasound to exclude deep vein thrombosis in the under extremities in patients referred to a medical department suspected of having deep vein thrombosis. The main aim is to answer are if a machine learning algorithm and point of care D-dimer can exclude deep vein thrombosis in more patients than clinical assessment and D-dimer alone.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
All participants will follow the usual diagnostic algorithm used for patients with suspected DVT referred to Ostfold Hospital (all patients are examined by a physician, D-dimer is analyzed in all patients, ultrasound is performed by a radiologist in patients with positive D-dimer). In addition to usual care, POC D-dimer, POC ultrasound (performed by ED physicians), blood sampling for biobanking, and photographies of the under extremities will be performed. The machine learning model will be tested to see if the prediction is correct. In participants where ultrasound is performed, it will also be assessed whether the machine learning algorithm could have excluded the participant without the use of ultrasound. None of the additional procedures will have any impact on the patient diagnostics or treatment.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Waleed Ghanima, Professor
- 전화번호: 0047 69860000
- 이메일: waleed.ghanima@so-hf.no
연구 연락처 백업
- 이름: Hans Joakim Myklebust-Hansen, Medical Doctor
- 전화번호: 0047 97501765
- 이메일: hans.joakim.hansen@so-hf.no
연구 장소
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Sarpsborg, 노르웨이, 1714
- 모병
- Østfold Hospital Trust
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연락하다:
- Hans J Myklebust-Hansen, M.D.
- 전화번호: 004797501765
- 이메일: hansjoakim_mh@outlook.com
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부수사관:
- Hans J Myklebust-Hansen, M.D.
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients referred to the ED due to suspicion of DVT
- Age ≥ 18 years
- Able to give informed consent
Exclusion Criteria:
- Ongoing use of anticoagulation for more than 72 hours
- Previous participation in the study
- Life expectancy of less than three months.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: All participants
All participants will be treated the same way. |
POC D-dimer will be compared to laboratory D-dimer in hospital setting and used in a machine learning model Point of care (POC) ultrasound performed by ED physicians compared to ultrasound performed by radiologist. POC ultrasound 3 point examination performed by ED physician will be compared with POC ultrasound full leg examination performed by ED physician. The DSS will be compared to the usual strategy. It will also be estimated how many participants where DVT could have been excluded without ultrasound.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety of the new strategy (POC D-dimer, ML-based prediction model, POC CUS by emergency physician)
기간: From enrollment to the end of the primary assessment period (90 days)
|
Evaluate the safety of a new strategy consisting of POC D-dimer and an ML-based prediction model followed by CUS performed by emergency physicians by comparing the new strategy's safety with our standard care by measuring the proportion of patients in whom DVT is excluded according to the new strategy but was diagnosed with DVT by standard care or in whom DVT is diagnosed within the 90-day follow up. |
From enrollment to the end of the primary assessment period (90 days)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluate the efficiency of the new strategy
기간: From enrollment to the end of the primary assessment period (90 days)
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The proportion of patients in whom DVT can be ruled out by the ML-based prediction model with POC D-dimer compared to the efficiency of Wells score and laboratory D-dimer |
From enrollment to the end of the primary assessment period (90 days)
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Validate the safety and efficiency of the ML-based prediction model
기간: From enrollment to the end of the primary assessment period (90 days)
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Safety will be determined by the proportion of patients in whom DVT is excluded by the ML-model but diagnosed by standard care. Efficiency will be determined by the proportion of patients in whom DVT can be excluded by the ML-based model |
From enrollment to the end of the primary assessment period (90 days)
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Evaluate concordance between CUS performed by emergency physicians and radiologists.
기간: From time of enrollment until time of ultrasound examination performed by radiologist, assessed up to 48 hours.
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Determine the proportion of false negative and false positive diagnosis of DVT in emergency physician-performed ultrasound compared with ultrasound performed by radiologists. |
From time of enrollment until time of ultrasound examination performed by radiologist, assessed up to 48 hours.
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Evaluate concordance between POC D-dimers in an ED setting and laboratory D-dimers.
기간: From enrollment to the completion of D-dimer analysis, assessed up to 24 hours.
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Compare the two POC D-dimers with the STA-Liatest D-dimer and Siemens INNOVANCE by direct comparison of the true/false positive/negative results. |
From enrollment to the completion of D-dimer analysis, assessed up to 24 hours.
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Evaluate the hypothetical time to be completed for the novel strategy compared to the standard strategy.
기간: From time of enrollment until time of discharge from the emergency department either discharged from the hospital or hospitalized, assessed up to 24 hours.
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Estimating the total management time defined as time from ED registration to ED discharge in patients evaluated according to the new strategy compared to standard care. |
From time of enrollment until time of discharge from the emergency department either discharged from the hospital or hospitalized, assessed up to 24 hours.
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Evaluate the safety of a limited ultrasound protocol (two-point and proximal) compared to full-leg CUS performed by emergency physicians and radiologists
기간: 90 days after enrollment.
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Estimating the proportion of patients in whom DVT was ruled out by the limited ultrasound protocol but was diagnosed with DVT by the whole-leg ultrasound. |
90 days after enrollment.
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공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- 682139
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The plan to share IPD with other researchers are not yet decided because it has not yet been discussed.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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