CancerREDUCENCT05229471
Management of Recurrent Venous Thromboembolism During Anticoagulant Treatment in Cancer Patients - a Prospective Cohort Study
An observational study of Cancer and Venous Thromboembolism, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in 3 countries.
Trial summary
Objective: To prospectively evaluate clinical outcomes during guideline-recommended LMWH dose escalation for recurrent VTE during LMWH or DOAC treatment for cancer-associated thrombosis. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cancer, Venous Thromboembolism, Recurrence
- How many people
- 220 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 2 Jun 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unselected adult cancer patients who develop symptomatic or incidental recurrent VTE while receiving appropriate doses of LMWH or DOACs for an acute VTE.
Who may be able to join
- Documented active cancer (i.e. diagnosis of cancer within the past 6 months; recurrent, regionally advanced, or metastatic disease; currently receiving treatment or received treatment within the past 6 months)
- Objectively confirmed symptomatic or incidental recurrent VTE while on anticoagulant therapy. The previous VTE and index recurrent VTE will include symptomatic or incidentally detected proximal deep vein thrombosis (DVT) of the lower extremities; symptomatic proximal upper extremity DVT (either related to a catheter or not); symptomatic distal DVT; symptomatic or incidentally detected multiple subsegmental, segmental or more proximal pulmonary embolism (PE).
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Use of thrombolysis
- Anticoagulant treatment for the recurrent VTE for longer than 72 hours
- Treatment with fondaparinux, unfractionated heparin, prophylactic doses of LMWH, or VKAs at time of recurrent VTE
- Acute hepatitis, chronic active hepatitis, or severe hepatic dysfunction (Child Pugh C or <MELD > 10)
- Active bleeding
Show all 16Show fewer
- Recent major surgery (<2 weeks or longer, if still at high risk for bleeding)
- Uncontrolled hypertension (systolic arterial pressure >160 mmHg)
- Known bleeding diathesis
- Platelet count <50.000 mm3
- Creatinine clearance <30 mL/min (Cockcroft-Gault formula)
- Life expectancy of less than 1 month
- Dual antiplatelet therapy or aspirin at doses ≥165 mg daily
- Current diagnosis or history of heparin-induced thrombocytopenia
- Any condition, which in the opinion of the investigator, would put the subject at an unacceptable risk from participating in the study.
- Suspected non-compliance at the time of recurrent VTE
Trial locations and contacts
9 sites in 3 countries.
Marcello Di Nisio, Dr. contact
9 sites in 3 countries
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitario Puerto Real
Cadiz
Juan Bosco López-Saez
- Recruiting
hospital general universitario de Elche
Elche
Francisco J. Pelegrín Mateo
- Recruiting
Clínica Universidad Navarra en Madrid
Madrid
Pedro Ruiz-Artacho
- Recruiting
Clinica Universidad de Navarra
Pamplona
Sofia Huerga Domínguez
- Recruiting
Hospital Universitario Virgen del Rocío
Seville
Luis Jara-Palomares
Netherlands3 sites, 3 recruiting
- Recruiting
Meander Medisch Centrum
Amersfoort
Hans-Martin Otten
- Recruiting
Amsterdam UMC, location AMC
Amsterdam
Floris Bosch
- Recruiting
Leids Universitair Merisch Centrum
Leiden
Erik Klok, Dr.
Italy1 site, 1 recruiting
- Recruiting
Gabriele D'Annunzio University
Chieti
Marcello Di Nisio
About this study
Objective: To prospectively evaluate clinical outcomes during guideline-recommended LMWH dose escalation for recurrent VTE during LMWH or DOAC treatment for cancer-associated thrombosis.
Study design: International, prospective, observational cohort study Study population: Adult cancer patients with symptomatic or incidental recurrent VTE while receiving LMWH or DOACs for acute VTE are eligible. Main exclusion criteria include anticoagulant treatment for the recurrent VTE for more than 72 hours, severe hepatic dysfunction, active bleeding, recent major surgery, uncontrolled hypertension, known bleeding diathesis, and a life expectancy of less than 1 month.
Read more
Study procedures: Patients will be managed at the discretion of the treating physician, who will be encouraged to follow guideline recommendations. These guidelines suggest supra-therapeutic dose LMWH for 4 weeks (+/- 5 days) followed by therapeutic dose LMWH or therapeutic dose DOAC, while it is suggested to treat patients with VTE recurrence during maintenance dose LMWH (i.e. 75 to 80% of full therapeutic weight adjusted dose) with therapeutic dose of LMWH or DOAC.
Main study parameters/endpoints: The co-primary outcomes are new symptomatic or incidental recurrent VTE during 3 months of follow-up and on-treatment major bleeding. Secondary outcomes include recurrent incidental VTE, recurrent symptomatic VTE, recurrent incidental or symptomatic proximal or distal DVT, recurrent incidental or symptomatic PE, clinically relevant non-major bleeding, all-cause mortality, and cancer-related mortality. VTE occurring at other sites such as cerebral DVT or splanchnic DVT will also be recorded.
- Conditions
- Cancer, Venous Thromboembolism, Recurrence
- Medical subject headings
- Neoplasms, Venous Thromboembolism, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent venous thromboembolism
objectively confirmed recurrent VTE
Measured: 90 days
Major bleeding
Major bleeding per ISTH criteria
Measured: 90 days
Secondary outcomes (1)
Clinically relevant non-major bleeding
CRNMB per ISTH criteria
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start2 Jun 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- G. d'Annunzio University
- Responsible party
- Principal investigator, Harry R. Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229471
- Sponsor's protocol ID
- W19_237
- Acronym
- REDUCE
- Status last verified
- Jul 2023
- First submitted
- 28 Jan 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researchers are open to discussing plans for data sharing on IPD analysis.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Recurrent Venous Thromboembolism During Anticoagulant Treatment in Cancer Patients - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05229471
- Acronym / sponsor ID
- REDUCE / W19_237
- Conditions
- Cancer, Venous Thromboembolism, Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- G. d'Annunzio University
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To prospectively evaluate clinical outcomes during guideline-recommended LMWH dose escalation for recurrent VTE during LMWH or DOAC treatment for cancer-associated thrombosis.
Study design: International, prospective, observational cohort study Study population: Adult cancer patients with symptomatic or incidental recurrent VTE while receiving LMWH or DOACs for acute VTE are eligible. Main exclusion criteria include anticoagulant treatment for the recurrent VTE for more than 72 hours, severe hepatic dysfunction, active bleeding, recent major surgery, uncontrolled hypertension, known bleeding diathesis, and a life expectancy of less than 1 month.
Study procedures: Patients will be managed at the discretion of the treating physician, who will be encouraged to follow guideline recommendations. These guidelines suggest supra-therapeutic dose LMWH for 4 weeks (+/- 5 days) followed by therapeutic dose LMWH or therapeutic dose DOAC, while it is suggested to treat patients with VTE recurrence during maintenance dose LMWH (i.e. 75 to 80% of full therapeutic weight adjusted dose) with therapeutic dose of LMWH or DOAC.
Main study parameters/endpoints: The co-primary outcomes are new symptomatic or incidental recurrent VTE during 3 months of follow-up and on-treatment major bleeding. Secondary outcomes include recurrent incidental VTE, recurrent symptomatic VTE, recurrent incidental or symptomatic proximal or distal DVT, recurrent incidental or symptomatic PE, clinically relevant non-major bleeding, all-cause mortality, and cancer-related mortality. VTE occurring at other sites such as cerebral DVT or splanchnic DVT will also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unselected adult cancer patients who develop symptomatic or incidental recurrent VTE while receiving appropriate doses of LMWH or DOACs for an acute VTE.
Key inclusion criteria (2 listed)
- Documented active cancer (i.e. diagnosis of cancer within the past 6 months; recurrent, regionally advanced, or metastatic disease; currently receiving treatment or received treatment within the past 6 months)
- Objectively confirmed symptomatic or incidental recurrent VTE while on anticoagulant therapy. The previous VTE and index recurrent VTE will include symptomatic or incidentally detected proximal deep vein thrombosis (DVT) of the lower extremities; symptomatic proximal upper extremity DVT (either related to a catheter or not); symptomatic distal DVT; symptomatic or incidentally detected multiple subsegmental, segmental or more proximal pulmonary embolism (PE).
Key exclusion criteria (16 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Use of thrombolysis
- Anticoagulant treatment for the recurrent VTE for longer than 72 hours
- Treatment with fondaparinux, unfractionated heparin, prophylactic doses of LMWH, or VKAs at time of recurrent VTE
- Acute hepatitis, chronic active hepatitis, or severe hepatic dysfunction (Child Pugh C or <MELD > 10)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrent venous thromboembolism
Time frame: 90 days
objectively confirmed recurrent VTE
Major bleeding
Time frame: 90 days
Major bleeding per ISTH criteria
1 secondary outcome
Clinically relevant non-major bleeding
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided. Researchers are open to discussing plans for data sharing on IPD analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcello Di Nisio, Dr. contact
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Venous Thromboembolism, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Netherlands, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Floris Bosch, Drs. (0031 20 5668791, f.t.bosch@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent venous thromboembolism (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.