ThrombosisMeTHOSNCT04248348
Metaxa Hospital THromboprophylaxis Program in Oncological & Surgical Patients
An observational study of Thrombosis and Solid Cancer, run by Metaxa Hospital at 1 site in Greece.
Trial summary
During MeTHOS study will be collected Real World Data the clinical practice regarding Thromboprophylaxis in high thrombotic risk solid tumors patients undergoing surgical and /or chemotherapeutical treatment, for one year following the protocol initiation date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Solid Cancer
- What is being tested?
- Low Molecular Weight Heparin
- How many people
- 600 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2018to Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Solid cancer patients
Who may be able to join
- Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy >6 months
- Signed informed consent
Who cannot join
- Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery
- Age < 18 years
- ECOG performance status >2
- Life expectancy <6 months
- Not signed informed consent
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Metaxa Hopital
Piraeus, Attica
Nikos Ziras, MD
Spyridon Xynogalos, MD
About this study
Official title: Metaxa's Thromboprophylaxis Program in Oncological & Surgical Patients
During MeTHOS study will be collected Real World Data the clinical practice regarding Thromboprophylaxis in high thrombotic risk solid tumors patients undergoing surgical and /or chemotherapeutical treatment, for one year following the protocol initiation date.
Specifically focus will be on the following:
- Number of thrombotic events
- Anti-thrombotic management dosage \& duration
- Any bleedings related to anticoagulation
- Patients' adherence and compliance
- Conditions
- Thrombosis, Solid Cancer
- Being tested
- Low Molecular Weight Heparin
- Keywords
- Thrombosis, Cancer, Heparin, Low Molecular Weight
- Medical subject headings
- Thrombosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Molecular Weight HeparinDrug
Cancer patients will be protected against thrombosis using Low Molecular Weight Heparin (LMWH)
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of thrombotic events
Measure the number of thrombotic events in the population
Measured: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Number of bleedings related to anticoagulation
Measure the number of observed bleeding events caused by the anticoagulation treatment
Measured: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Secondary outcomes (4)
Anticoagulation drug dosage
Record the antithrombotic drug dosage (IU/day), aiming to investigate the role of dosage for thrombotic events and bleedings (primary outcomes)
Measured: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Anticoagulation drug duration
Record the antithrombotic drug duration (in days). The aim is to investigate the role of antithrombotic duration for thrombotic events and bleedings (primary outcomes)
Measured: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Patients' compliance to anticoagulation treatment
Record the compliance of patients' in antithrombotic treatment. A patient is considered to be compliant if the anticoagulation treatment was administered as prescribed (usually every day), otherwise it is non-compliant. The aim is to investigate the role of patient compliance for thrombotic events and bleedings (primary outcomes).
Measured: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Anticoagulation drug agent
Record the anticoagulation drug agent. The aim is to investigate the role of different agents for thrombotic events and bleedings (primary outcomes)
Measured: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Dec 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metaxa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Ziras, Metaxa Hospital
- Investigators
- Nikos Ziras, MD, Study chair, Metaxa HospitalSpyridon Xynogalos, MD, Principal investigator, Metaxa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248348
- Sponsor's protocol ID
- 2394-05/02/2019
- Acronym
- MeTHOS
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be provided upon a reasonable request.
Publications
Xynogalos S, Simeonidis D, Papageorgiou G, Pouliakis A, Charalambakis N, Lianos E, Mazlimoglou E, Liatsos AN, Kosmas C, Ziras N. Can thromboprophylaxis build a link for cancer patients undergoing surgical and/or chemotherapy treatment? The MeTHOS cohort study. Support Care Cancer. 2022 Aug;30(8):6973-6984. doi: 10.1007/s00520-022-07096-1. Epub 2022 May 12.
PubMed 35552827
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metaxa's Thromboprophylaxis Program in Oncological & Surgical Patients
- ClinicalTrials.gov ID
- NCT04248348
- Acronym / sponsor ID
- MeTHOS / 2394-05/02/2019
- Conditions
- Thrombosis, Solid Cancer
- Keywords
- Thrombosis, Cancer, Heparin, Low Molecular Weight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Metaxa HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Jan 2020 (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.
During MeTHOS study will be collected Real World Data the clinical practice regarding Thromboprophylaxis in high thrombotic risk solid tumors patients undergoing surgical and /or chemotherapeutical treatment, for one year following the protocol initiation date.
Specifically focus will be on the following:
- Number of thrombotic events
- Anti-thrombotic management dosage \& duration
- Any bleedings related to anticoagulation
- Patients' adherence and compliance
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Solid cancer patients
Key inclusion criteria (5 listed)
- Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy >6 months
- Signed informed consent
Key exclusion criteria (5 listed)
- Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery
- Age < 18 years
- ECOG performance status >2
- Life expectancy <6 months
- Not signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Molecular Weight HeparinCancer patients will be protected against thrombosis using Low Molecular Weight Heparin (LMWH) | Drug | – |
Primary outcome
Number of thrombotic events
Time frame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Measure the number of thrombotic events in the population
Number of bleedings related to anticoagulation
Time frame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Measure the number of observed bleeding events caused by the anticoagulation treatment
4 secondary outcomes
Anticoagulation drug dosage
Time frame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Anticoagulation drug duration
Time frame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Patients' compliance to anticoagulation treatment
Time frame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Anticoagulation drug agent
Time frame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 35552827Xynogalos S, Simeonidis D, Papageorgiou G, Pouliakis A, Charalambakis N, Lianos E, Mazlimoglou E, Liatsos AN, Kosmas C, Ziras N. Can thromboprophylaxis build a link for cancer patients undergoing surgical and/or chemotherapy treatment? The MeTHOS cohort study. Support Care Cancer. 2022 Aug;30(8):6973-6984. doi: 10.1007/s00520-022-07096-1. Epub 2022 May 12.
- Individual participant dataSharing planned: Undecided. Data may be provided upon a reasonable request.
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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.
Nikos Ziras, MD study chair
Metaxa Hospital
Spyridon Xynogalos, MD principal investigator
Metaxa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis and Solid Cancer, run by Metaxa Hospital at 1 site in Greece.
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 5 inclusion and 5 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 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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 Nikos Ziras, MD (+306932748495, zirasngr@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of thrombotic events (time frame: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)). 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?
On the ClinicalTrials.gov record for NCT04248348, which also lists 1 linked publication.
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 30 Jan 2020.