암 및 카테터 관련 상지 심부 정맥 혈전증 환자에서 VTE의 이차 예방 (STREAM-Line)
암 및 카테터 관련 상지 심부 정맥 혈전증 환자의 정맥 혈전색전증의 이차 예방(STREAM-Line 연구)
This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT).
연구 개요
상세 설명
The aim of the STREAM-Line Trial is to demonstrate that the STREAM-Line management strategy is safe after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) in patients with cancer and catheter-related upper extremity DVT. Upon enrollment and during follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally twice daily) as long as either a central venous catheter (CVC) or active cancer is present (STREAM-Line management strategy). Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Day 90±14 and Day 180+14 follow-up visit procedures will be done by phone call or in person.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Tzu-Fei Wang, MD, MPH
- 전화번호: 73755 6137379988
- 이메일: tzwang@toh.ca
연구 장소
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Ontario
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Ottawa, Ontario, 캐나다, K1H 8L6
- 모병
- The Ottawa Hospital
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연락하다:
- Cecilia Germano
- 이메일: cegermano@ohri.ca
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Sault Ste. Marie, Ontario, 캐나다
- 모병
- Sault Area Hospital
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연락하다:
- Natalie Walde
- 이메일: walden@sah.on.ca
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Adult patients (≥ 18 years old) with active cancer, defined as cancer (other than localized non-melanoma skin cancer) diagnosed or treated within 6 months, or the presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer therapy, or hematological malignancy not in complete remission.
Objectively confirmed catheter-related upper extremity DVT and treated with any standard therapeutic anticoagulation (including LMWH dose reduction to 75% after the first month) for at least 3 months.
Able and willing to provide informed consent.
Exclusion Criteria:
Active bleeding or other reasons for which anticoagulation is contraindicated.
Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.).
Anticoagulation has been permanently stopped or reduced to prophylactic dose for > 5 days prior to enrollment for any reasons.
Pregnancy or breast feeding in patients who are prescribed a direct oral anticoagulant.
Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 and P-glycoprotein in patients who are prescribed a direct oral anticoagulant.
Cancer is in remission and CVC is removed prior to enrollment.
Requirement of dual antiplatelet therapies.
Platelet count < 50 x 109/L or creatinine clearance < 30 ml/min.
Life expectancy of less than 3 months.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Apixaban
2.5 mg twice daily |
Patients will be enrolled after at least 3 months of therapeutic anticoagulation for an acute catheter-related upper extremity DVT while they are treated with therapeutic anticoagulation as standard of care. After enrollment, patients will be managed with prophylactic dose of anticoagulation as long as either a CVC or active cancer is present. If cancer goes into remission, at the time of CVC removal, anticoagulation will be stopped, but patients will continue to be followed until the end of the study at 6 months.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Venous Thromboembolism (VTE) Rate
기간: 6 months
|
The rates of symptomatic, objectively confirmed new or recurrent major VTE (proximal upper or lower extremity DVT, segmental or larger pulmonary embolism (PE)) with corresponding 95% Confidence Interval (CI) at 6 months. |
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Major Venous Thromboembolism (VTE) and Major bleeding Rate
기간: 3 months
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Rates of new/recurrent symptomatic major VTE and major bleeding at 3 months. |
3 months
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New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).
기간: 3 months and 6 months
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New/recurrent symptomatic catheter-related upper extremity DVT. |
3 months and 6 months
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New incidental Venous Thromboembolism (VTE)
기간: 3 months and 6 months
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New incidental VTE (PE or upper or lower extremity DVT), defined as VTE diagnosed on imaging studies obtained not for concern of VTE, such as cancer staging scans. |
3 months and 6 months
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New Deep Vein Thrombosis (DVT)
기간: 3 months and 6 months
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New/recurrent any distal upper or lower extremity DVT or subsegmental PE. |
3 months and 6 months
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Superficial vein thrombosis of upper or lower extremities
기간: 3 months and 6 months
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Superficial vein thrombosis of upper or lower extremities |
3 months and 6 months
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New unusual site Venous Thromboembolism (VTE)
기간: 3 months and 6 months
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New unusual site VTE (such as splanchnic vein, cerebral vein, or gonadal vein thrombosis). |
3 months and 6 months
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Clinically Relevant Non-Major Bleeding (CRNMB) events
기간: 3 months and 6 months
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CRNMB events by International Society on Thrombosis and Haemostasis (ISTH) criteria2 and composite major bleeding and CRNMB events. |
3 months and 6 months
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Arterial thromboembolic events
기간: 3 months and 6 months
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Arterial thromboembolic events (objectively confirmed), including myocardial infarction, stroke, peripheral arterial disease, or other systemic arterial embolism. |
3 months and 6 months
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All-cause mortality
기간: 3 months and 6 months
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All-cause mortality |
3 months and 6 months
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Correlative biomarkers
기간: 6 months
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Correlative biomarkers at 6 months, while the exact list of correlative biomarkers is to be determined at the time of study completion, examples include D-dimer, P-selectin, prothrombin F1+F2, thrombin generation, etc. |
6 months
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Health-related quality of life using the EuroQoL-5D-5L Questionnaire
기간: 6 months
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Health-related quality of life using EuroQoL-5D-5L (5Dimension- mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5L- severity levels) questionnaires on enrollment and at 6 months. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state. |
6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Tzu-Fei Wang, MD, MPH, Ottawa Hospital Research Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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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