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Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy (HYDRA)

Primary Purpose

Pulmonary Embolism

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

YEARS

CTPA

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

Clinically suspected PE as judged by the treating clinician
Any type of active malignancy (other than basal-cell or squamous-cell carcinoma of the skin), defined as diagnosis within six months before the study inclusion (as confirmed histologically or high suspicion as judged by the clinician), receiving treatment for malignancy at time of inclusion or during 6 months prior to randomization, including recurrent or local metastatic malignancy
Outpatients and hospitalized patients
Age ≥ 18 years
Signed and dated informed consent, available for start of the trial procedure

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months, or unwillingness to sign informed consent
Treatment with full-dose therapeutically dosed anticoagulation that was initiated 24 hours or more prior to eligibility assessment
Contraindication to CTPA
- contrast allergy

Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise), indicated by at least one of the following:

systolic blood pressure (SBP) < 100 mm Hg, or heart rate >120 beats per minute or SBP drop by > 40 mm Hg, for > 15 min
need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of > 100 mmHg
Need for cardiopulmonary resuscitation
Inability to follow-up
Life expectancy less than 3 months

Sites / Locations

CHU Angers
CHRU BrestRecruiting
CHU Clermont-Ferrand
Hôpital Louis Mourier - APHP
HEGP
CHU Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

YEARS algorithm

CTPA as single test

Arm Description

Patients randomized to this arm will be evaluated according to the YEARS algorithm.

Patients randomized to this arm will undergo a contrast enhanced CTPA.

Outcomes

Primary Outcome Measures

Recurrent PE

Recurrent PE will be observed

Deep vein thrombosis (DVT)

Number of DVT will be observed

Mortality

The mortality will be observed

Secondary Outcome Measures

CTPA

Number of performed CTPA will be observed

Full Information

NCT ID

NCT04657120

First Posted

December 1, 2020

Last Updated

March 17, 2022

Sponsor

University Hospital, Brest

1. Study Identification

Unique Protocol Identification Number

NCT04657120

Brief Title

Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy

Acronym

HYDRA

Official Title

Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy : HYDRA Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (CTPA) alone in a randomized study.

Detailed Description

Recently, the YEARS-algorithm was demonstrated to be a safe and efficient diagnostic strategy for patients with clinically suspected pulmonary embolism (PE). It is recognized that diagnostic algorithms for pulmonary embolism (PE) may not be as effective and safe in patients with malignancy, due to the low specificity of D-dimer test in that setting. A diagnostic algorithm that could safely rule out PE in patients with malignancy without performing computed tomography pulmonary angiography (CTPA) could nonetheless improve patient care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Embolism

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

YEARS algorithm

Arm Type

Experimental

Arm Description

Patients randomized to this arm will be evaluated according to the YEARS algorithm.

Arm Title

CTPA as single test

Arm Type

Active Comparator

Arm Description

Patients randomized to this arm will undergo a contrast enhanced CTPA.

Intervention Type

Procedure

Intervention Name(s)

YEARS

Intervention Description

Patients randomized to the YEARS algorithm will be evaluated according to the YEARS algorithm consisting of three items of the original Wells rule (clinical signs of DVT, hemoptysis and 'PE most likely diagnosis') and a D-dimer test. In patients without any of the three items and a D-dimer level <1.0 μg/mL, and in patients with ≥1 items and a D-dimer level <0.5 μg/mL a PE is excluded without CTPA. In the other patients a standard contrast enhanced CTPA will be performed according to local practice. PE is defined as at least one filling defect in the pulmonary artery tree on CTPA.

Intervention Type

Procedure

Intervention Name(s)

CTPA

Intervention Description

Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.

Primary Outcome Measure Information:

Title

Recurrent PE

Description

Recurrent PE will be observed

Time Frame

3 months

Title

Deep vein thrombosis (DVT)

Description

Number of DVT will be observed

Time Frame

3 months

Title

Mortality

Description

The mortality will be observed

Time Frame

3 months

Secondary Outcome Measure Information:

Title

CTPA

Description

Number of performed CTPA will be observed

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Clinically suspected PE as judged by the treating clinician Any type of active malignancy (other than basal-cell or squamous-cell carcinoma of the skin), defined as diagnosis within six months before the study inclusion (as confirmed histologically or high suspicion as judged by the clinician), receiving treatment for malignancy at time of inclusion or during 6 months prior to randomization, including recurrent or local metastatic malignancy Outpatients and hospitalized patients Age ≥ 18 years Signed and dated informed consent, available for start of the trial procedure Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months, or unwillingness to sign informed consent Treatment with full-dose therapeutically dosed anticoagulation that was initiated 24 hours or more prior to eligibility assessment Contraindication to CTPA contrast allergy Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise), indicated by at least one of the following: systolic blood pressure (SBP) < 100 mm Hg, or heart rate >120 beats per minute or SBP drop by > 40 mm Hg, for > 15 min need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of > 100 mmHg Need for cardiopulmonary resuscitation Inability to follow-up Life expectancy less than 3 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francis COUTURAUD, Pr

Phone

02 98 34 73 47

Ext

+33

francis.couturaud@chu-brest.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis COUTURAUD, Pr

Organizational Affiliation

CHRU Brest

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Angers

City

Angers

ZIP/Postal Code

49933

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre-Marie ROY, Pr

Phone

02 41 35 66 50

Ext

+33

PMRoy@chu-angers.fr

Facility Name

CHRU Brest

City

Brest

ZIP/Postal Code

29609

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francis COUTURAUD, Pr

Phone

02 98 34 73 47

Ext

+33

francis.couturaud@chu-brest.fr

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeannot SCHMIDT, Pr

Phone

04 73 75 19 99

Ext

+33

jschmidt@chu-clermontferrand.fr

Facility Name

Hôpital Louis Mourier - APHP

City

Colombes

ZIP/Postal Code

92700

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle MAHE, Pr

Phone

01 47 60 64 90

Ext

+33

isabelle.mahe@lmr.aphp.fr

Facility Name

HEGP

City

Paris

ZIP/Postal Code

75015

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guy MEYER, Pr

Phone

01 65 09 34 61

Ext

+33

guy.meyer@aphp.fr

Facility Name

CHU Saint-Etienne

City

Saint-Étienne

ZIP/Postal Code

42055

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurent BERTOLETTI, Dr

Phone

04 77 12 77 70

Ext

+33

laurent.bertoletti@chu-st-etienne.fr

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Learn more about this trial

Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy

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