Metaxa Hospital THromboprophylaxis Program in Oncological & Surgical Patients

Thrombosis Clinical Trial

— MeTHOS  

Official title:

Metaxa's Thromboprophylaxis Program in Oncological & Surgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04248348
• Other study ID #: 2394-05/02/2019
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: Metaxa Hospital
• Contact: Nikos Ziras, MD
• Phone: +306932748495
• Email: zirasngr[@]otenet.gr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery

2. Age = 18 years

3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

4. Life expectancy >6 months

5. Signed informed consent

Exclusion Criteria

1. Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery

2. Age < 18 years

3. ECOG performance status >2

4. Life expectancy <6 months

5. Not signed informed consent

Related Conditions & MeSH terms

• Solid Cancer
• Thrombosis

Intervention

Drug:
• Low Molecular Weight Heparin
Cancer patients will be protected against thrombosis using Low Molecular Weight Heparin (LMWH)

Locations

Country	Name	City	State
Greece	Metaxa Hopital	Piraeus	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Metaxa Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of thrombotic events	Measure the number of thrombotic events in the population	Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Primary	Number of bleedings related to anticoagulation	Measure the number of observed bleeding events caused by the anticoagulation treatment	Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Secondary	Anticoagulation drug dosage	Record the antithrombotic drug dosage (IU/day), aiming to investigate the role of dosage for thrombotic events and bleedings (primary outcomes)	Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Secondary	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)	Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Secondary	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).	Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Secondary	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)	Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)