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Viscoelastic Coagulation Monitoring for Early Identification of Sepsis: The VISION II Study (VISION II)

2026년 11월 3일 업데이트: Hellenic Institute for the Study of Sepsis

Viscoelastic Coagulation Monitor as an Early Index of Sepsis in Patients Admitted With Infection at the Emergency Department: The VISION II Study

The VISION II study is a prospective, multicenter, observational cohort study evaluating the diagnostic performance of Viscoelastic Coagulation Monitor (VCM) parameters for the early identification of sepsis in adults presenting to the Emergency Department with suspected infection.The previous single-center, proof-of-concept VISION study (NCT07073456) showed that shorter clotting time (CT) was independently associated with sepsis and that patients with sepsis accumulated a greater number of out-of-range VCM measurements during follow-up. Although CT demonstrated potential for distinguishing between patients with and without sepsis, its diagnostic performance was moderate, supporting further evaluation in a larger, multicenter cohort.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Sepsis is frequently associated with hemostatic disturbances resulting from the close interaction between inflammation and coagulation. These alterations may occur early in the course of infection but may not be adequately detected by conventional coagulation tests. The Viscoelastic Coagulation Monitor (VCM) is a point-of-care device that provides a rapid bedside assessment of whole-blood clot formation and may therefore support the early identification of patients progressing to sepsis.

In the previous single-center, prospective, proof-of-concept VISION study, VCM parameters were evaluated in adults presenting to the Emergency Department with suspected infection. Shorter clotting time (CT) remained independently associated with sepsis after adjustment for established clinical scores and laboratory biomarkers. Patients with sepsis also accumulated a greater number of out-of-range VCM measurements during follow-up. However, the diagnostic performance of CT was moderate, indicating the need for validation in a larger, multicenter cohort. Moreover, patients receiving anticoagulant or antiplatelet therapy were excluded from the previous study, limiting the applicability of its findings to routine Emergency Department practice.

VISION II is a prospective, observational, multicenter study designed to evaluate the diagnostic performance of VCM parameters for the early identification of sepsis in approximately 400 adults presenting to the Emergency Department with suspected infection. Unlike the previous study, VISION II will include patients receiving chronic anticoagulant or antiplatelet therapy and will assess the potential effect of these treatments on VCM parameters and diagnostic performance.

VCM testing and clinical and laboratory assessments will be performed at enrollment and, for patients who remain hospitalized, at 24, 48, and 72 hours. Recorded assessments will include SOFA-2, qSOFA, NEWS2 scores, conventional coagulation parameters, inflammatory biomarkers, microbiological findings, administered antibiotic therapy, admission to the Intensive Care Unit, survival status, and major thromboembolic events.

The primary endpoint is the difference in VCM-derived parameters between patients who develop sepsis within the first 72 hours and those who do not. Sepsis will be defined according to the Sepsis-3 criteria. Sepsis status will be independently determined by two clinical adjudicators who will review the available clinical data from the 72-hour follow-up period while remaining blinded to the VCM results.

연구 유형

관찰

등록 (추정된)

400

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Evangelos J. Giamarellos-Bourboulis, MD, PhD
  • 전화번호: 00302105831994
  • 이메일: egiamarel@med.uoa.gr

연구 장소

  • 그리스
    • Attica
      • Magoula, Attica, 그리스, 19600
        • Thriasio Eleusis General Hospital, First Department of Internal Medicine
        • 연락하다:
        • 수석 연구원:
          • Styliani Sympardi, MD, PhD
      • Nikaia, Attica, 그리스, 18454
        • Nikaia General Hospital of Piraeus "Agios Panteleimon" - West Attica General Hospital "Agia Varvara", Emergency Department (ED)
        • 연락하다:
        • 수석 연구원:
          • Dimitrios Tsiftis, MD, PhD
      • Piraeus, Attica, 그리스, 18536
        • Tzaneio General Hospital of Piraeus, Emergency Department
        • 연락하다:
        • 수석 연구원:
          • Styliani Gerakari, MD, PhD
    • Central Macedonia
      • Exochí, Central Macedonia, 그리스, 57010
        • G. Papanikolaou Thessaloniki General Hospital, Emergency Department
        • 연락하다:
        • 수석 연구원:
          • Eleni Peitsidou, MD, PhD
      • Thessaloniki, Central Macedonia, 그리스, 54636
        • AHEPA Thessaloniki University General Hospital, Emergency Department
        • 연락하다:
          • Varvara Fyntanidou, MD, PhD
          • 전화번호: 00306977427336
          • 이메일: bfyntan@yahoo.com
        • 수석 연구원:
          • Varvara Fyntanidou, MD, PhD
    • Chaidari
      • Athens, Chaidari, 그리스, 12462
        • 4th Department of Internal Medicine, ATTIKON University General Hospital, General Hospital of West Attica H Agia Varvara, National and Kapodistrian University of Athens, Medical School
        • 연락하다:
        • 수석 연구원:
          • Evangelos J. Giamarellos-Bourboulis, MD, PhD
      • Athens, Chaidari, 그리스, 12462
        • Emergency Medicine Department, ATTIKON University General Hospital, General Hospital of West Attica H Agia Varvara, NKUA
        • 연락하다:
        • 수석 연구원:
          • Ioannis Parisis, MD, PhD
    • South Aegean
      • Ermoupoli, South Aegean, 그리스, 84100
        • Syros General Hospital "Vardakeio and Proio" Department of Internal Medicine
        • 연락하다:
        • 수석 연구원:
          • Georgios Giannikopoulos, MD
    • Thessaly
      • Larissa, Thessaly, 그리스, 41221
        • General Hospital of Larissa "Koutlimpaneio and Triantafylleio"
        • 연락하다:
        • 수석 연구원:
          • Dimitrios Mpampalis, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Adult patients presenting to the Emergency Departments of participating hospitals with suspected infection who meet all inclusion criteria and none of the exclusion criteria will be enrolled in the study.

설명

Inclusion Criteria:

  • Male or female adults aged 18 years or older.
  • Written informed consent provided by the patient or, when the patient is unable to provide consent, by a legally authorized representative.
  • Suspected infection based on the predefined diagnostic criteria for infection sources specified in the study protocol and derived from published international guidelines.

Exclusion Criteria:

  • Age under 18 years.
  • Written informed consent not provided by the patient or, when applicable, by a legally authorized representative.
  • History of hemophilia or any other congenital coagulation disorder.
  • Known hematologic malignancy, regardless of disease stage.
  • Pregnancy or lactation.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
Patients with suspected infection

Adult patients presenting to the Emergency Department with suspected infection, as determined by the treating physician's clinical judgment and according to the predefined infection criteria specified in the study protocol.
진단 검사: Viscoelastic Coagulation Monitor (VCM) testing

Peripheral venous whole-blood samples will be collected for the assessment of eight parameters using the Viscoelastic Coagulation Monitor (VCM): clotting time (CT), clot formation time (CFT), alpha angle, amplitude at 10 minutes (A10), amplitude at 20 minutes (A20), maximum clot firmness (MCF), lysis index at 30 minutes (LI30), and lysis index at 45 minutes (LI45). Assessments will be performed at enrollment and, for patients who remain hospitalized, at 24, 48, and 72 hours. VCM results will not influence the patient's treatment or any other aspect of standard clinical care, which will remain entirely at the discretion of the treating physicians.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Differences in VCM parameters between patients who develop sepsis and those who do not
기간: From enrollment through 72 hours

The eight VCM-derived parameters will be compared between patients who develop sepsis and those who do not. Sepsis will be defined according to the Sepsis-3 criteria as suspected or confirmed infection accompanied by an increase of ≥2 points in the Sequential Organ Failure Assessment (SOFA)-2 score or more from baseline.
From enrollment through 72 hours

2차 결과 측정

결과 측정
측정값 설명
기간
Clotting Time in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
기간: From enrollment to 72 hours

Clotting time (CT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
From enrollment to 72 hours
Clot Formation Time in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
기간: At enrollment and at 24, 48, and 72 hours

Clot formation time (CFT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared using the Mann-Whitney U test between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours
Alpha Angle in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
기간: At enrollment and at 24, 48, and 72 hours.

Alpha angle, measured in degrees using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Amplitude at 10 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
기간: At enrollment and at 24, 48, and 72 hours.

Amplitude at 10 minutes (A10), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Maximum Clot Firmness in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
기간: At enrollment and at 24, 48, and 72 hours.

Maximum clot firmness (MCF), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Lysis Index at 30 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
기간: At enrollment and at 24, 48, and 72 hours.

Lysis index at 30 minutes (LI30), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Lysis Index at 45 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
기간: At enrollment and at 24, 48, and 72 hours.

Lysis index at 45 minutes (LI45), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Amplitude at 20 Minutes in Participants With and Without Chronic Anticoagulant or Antiplatelet Therapy
기간: At enrollment and at 24, 48, and 72 hours.

Amplitude at 20 minutes (A20), measured in VCM units, will be summarized as median and interquartile range and compared between participants receiving chronic anticoagulant or antiplatelet therapy and participants receiving neither therapy.
At enrollment and at 24, 48, and 72 hours.
Use of chronic anticoagulant therapy or antiplatelet therapy
기간: At enrollment

Number and proportion of enrolled patients receiving chronic anticoagulant therapy and those not receiving anticoagulant therapy.
At enrollment
Clotting Time in Participants With and Without a Major Thromboembolic Event
기간: At enrollment and at 24, 48, and 72 hours.

Clotting time (CT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants who develop a major thromboembolic event and participants who do not develop such an event within the first 72 hours after enrollment.
At enrollment and at 24, 48, and 72 hours.
Clot Formation Time in Participants With and Without a Major Thromboembolic Event
기간: At enrollment and at 24, 48, and 72 hours.

Clot formation time (CFT), measured in seconds using the VCM, will be summarized as median and interquartile range and compared between participants who develop a major thromboembolic event and participants who do not develop such an event within the first 72 hours after enrollment.
At enrollment and at 24, 48, and 72 hours.
Alpha Angle in Participants With and Without a Major Thromboembolic Event
기간: At enrollment and at 24, 48, and 72 hours.

Alpha angle, measured in degrees using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Amplitude at 10 Minutes in Participants With and Without a Major Thromboembolic Event
기간: At enrollment and at 24, 48, and 72 hours.

Amplitude at 10 minutes (A10), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Amplitude at 20 Minutes in Participants With and Without a Major Thromboembolic Event
기간: At enrollment and at 24, 48, and 72 hours.

Amplitude at 20 minutes (A20), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Lysis Index at 30 Minutes in Participants With and Without a Major Thromboembolic Event
기간: At enrollment and at 24, 48, and 72 hours.

Lysis index at 30 minutes (LI30), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Lysis Index at 45 Minutes in Participants With and Without a Major Thromboembolic Event
기간: At enrollment and at 24, 48, and 72 hours.

Lysis index at 45 minutes (LI45), measured as a percentage using the VCM, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Maximum Clot Firmness in Participants With and Without a Major Thromboembolic Event
기간: At enrollment and at 24, 48, and 72 hours.

Maximum clot firmness (MCF), measured in VCM units, will be summarized as median and interquartile range and compared between participants who experience a major thromboembolic event and participants who do not.
At enrollment and at 24, 48, and 72 hours.
Occurrence of sepsis among patients receiving chronic anticoagulant therapy
기간: From enrollment to 72 hours

Number and proportion of patients receiving chronic anticoagulant therapy who develop sepsis, as defined by the Sepsis-3 criteria, during the study follow-up period.
From enrollment to 72 hours
Cumulative number of out-of-range VCM parameters
기간: At enrollment and at 24, 48, and 72 hours

The cumulative number of VCM parameters outside their predefined reference ranges will be determined at enrollment and at 24, 48, and 72 hours and compared between patients who develop sepsis and those who do not.
At enrollment and at 24, 48, and 72 hours
Correlation between VCM parameters and inflammatory mediators
기간: At enrollment

Correlations between the eight VCM-derived parameters and measured inflammatory mediators and biomarkers, including interleukin-6 (IL-6), tissue factor (CD142), procalcitonin (PCT), and C-reactive protein (CRP), will be assessed.
At enrollment
Correlation between VCM parameters and conventional coagulation parameters
기간: At enrollment and, for hospitalized patients, at 24, 48, and 72 hours

Correlations between the eight VCM-derived parameters and conventional coagulation parameters, including international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, D-dimer levels, and platelet count, will be assessed.
At enrollment and, for hospitalized patients, at 24, 48, and 72 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hellenic Institute for the Study of Sepsis

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 1일

기본 완료 (추정된)

2027년 5월 1일

연구 완료 (추정된)

2027년 5월 1일

연구 등록 날짜

최초 제출

2026년 10월 23일

QC 기준을 충족하는 최초 제출

2026년 11월 3일

처음 게시됨 (실제)

2026년 11월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • VISION II

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

구독하다