CancerPhase 3NCT00311896
Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)
A Phase 3 study testing Bemiparin in people with Cancer and Thrombosis, run by Clinica Universidad de Navarra, Universidad de Navarra at 19 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the subcutaneous administration for 45 days of Bemiparin (3,500 UI/day) in cancer patients with a CVC, to prevent CVC-related deep venous thrombosis (CVC-DVT) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Thrombosis
- What is being tested?
- Bemiparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jul 2005to Dec 2010
- Phase
- Phase 3
- 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
Who may be able to join
- Patients over 18 years old of either sex who have given their informed consent to participate in the study.
- Patients with a neoplastic process, with a CVC for the administration of anti-tumoral treatment or any other treatment related to the neoplastic process.
- Patients with a platelet count above 30,000/mm3.
- Patients with no hemorrhagic symptomatology at the time of their inclusion
Who cannot join
- Patients with a history of clinically evident hemorrhagic episodes and/or with increased bleeding due to any other homeostatic alteration that contraindicates anticoagulant treatment and/or in the past two months have presented at least one of the following: active hemorrhaging or organic lesions susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular accident, aneurysms).
- Major surgery in the past two months.
- Known hypersensitivity to LMWH, heparin or substances of porcine origin.
- Patients with congenital or acquired bleeding diathesis.
- Damage to or surgical interventions of the central nervous system, eyes and ears within the past 6 months.
- Acute bacterial endocarditis or slow endocarditis.
Show all 15Show fewer
- Patients with a history of heparin-associated thrombocytopenia.
- Patients with severe renal failure (serum creatinine over 2 mg/dl) or hepatic insufficiency (with values of AST and/or ALT > 5 times the normal value established by the reference range of the local hospital laboratory).
- Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
- Patients with suspected inability/or inability to comply with treatment and/or complete the study.
- Patients who are participating in another clinical trial or have done so in the past 30 days.
- Patients with a life expectancy less than 3 months.
- Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
- Patients on treatment with anticoagulants or who have been on treatment during the week previous to insert the CVC (including prophylaxis with heparin for hepatic veno-occlusive disease).
- Patients diagnosed with acute leukemia or awaiting a transplant from hematopoietic progenitors during the 90 days of the study.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Spain11 sites
Hospital General de Alicante
Alicante
Hospital Germans Trias i Pujol
Barcelona
Hospital Santa Creu i Sant Pau
Barcelona
Complejo Hospitalario de Donostia
Donostia / San Sebastian
Hospital Clínico San Carlos-Madrid.
Madrid
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Morales Meseguer
Murcia
Clínica Universitaria de Navarra
Pamplona
Instituto Valenciano de Oncología
Valencia, 46009
Hospital Universitario Doctor Peset
Valencia
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Romania8 sites
Arad County Hospital
Arad
Cenral Emergency Clinical Military H.
Bucharest
Sf Maria Clinical Hospital
Bucharest
Oncology Institute Cuj-Napoca
Cluj-Napoca
University "CF" Clinical Hospital
Cluj-Napoca
Filantropia District Hospital
Craiova
Oncology Medical Center, Iasi
Iași
District Emergency Clinical Hospital
Târgu Mureş
About this study
Official title: Multicentric, Randomized, Placebo Controlled and Double-blind Study to Evaluate the Efficacy and Safety of Antithrombotic Prophylaxis With Bemiparin (3,500 UI/Day) in Cancer Patients With a Central Venous Catheter (CVC)(BECAT)
The purpose of this study is to evaluate the efficacy and safety of the subcutaneous administration for 45 days of Bemiparin (3,500 UI/day) in cancer patients with a CVC, to prevent CVC-related deep venous thrombosis (CVC-DVT)
Read the detailed description
Venous thromboembolism (VTE) is a common complication in patients with cancer principally in association with central vein catheters (CVC). The clinical benefit of antithrombotic prophylaxis for CVC-related VTE in cancer patients remains unclear.The aim of this study is to evaluate the efficacy and safety of the administration of Bemiparin in cancer patients with a central venous catheter (CVC). This study is designed as a multicenter, randomized, double-blind, placebo-controlled study. On the day of CVC insertion, eligible patients are randomly assigned to receive subcutaneously either bemiparin (3,500 UI/day) or placebo by using preloaded syringes for 45 days.
The primary efficacy endpoint will be the combined incidence during the double blind treatment period of Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography)and subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
- Conditions
- Cancer, Thrombosis
- Being tested
- Bemiparin, Placebo
- Keywords
- Cancer, Thrombosis, Catheter, Bemiparin, Prophylaxis
- Medical subject headings
- Neoplasms, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemiparinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Bemiparin | Experimental | Not described Receives: Drug: Bemiparin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).
Subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startJul 2005
- Primary completionFeb 2009
- Study completionDec 2010
Why it stopped: Sponsor stopped due to difficulties to recruit 402 patients required by protocol
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.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratorio farmacéutico ROVI
- Responsible party
- Sponsor
- Investigators
- Eduardo Rocha, MD, Study chair, Clinica Universitaria de NavarraRamon Lecumberri, MD, Principal investigator, Clinica Universitaria de NavarraVicente Vicente, MD, Principal investigator, Hospital Morales MeseguerPascual Marco, MD, Principal investigator, Hospital General Universitario de AlicanteJosé Mateo, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauAlbert Font, MD, Principal investigator, Germans Trias i Pujol HospitalCarmen Arratibel, MD, Principal investigator, Complejo Hospitalario de DonostiaFrancisco J. Capote, MD, Principal investigator, Hospital Universitario Puerta del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311896
- Sponsor's protocol ID
- ICT-BEM-2004-02
- Other IDs
- BECAT
- Status last verified
- Jun 2012
- First submitted
- 5 Apr 2006
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Randomized, Placebo Controlled and Double-blind Study to Evaluate the Efficacy and Safety of Antithrombotic Prophylaxis With Bemiparin (3,500 UI/Day) in Cancer Patients With a Central Venous Catheter (CVC)(BECAT)
- ClinicalTrials.gov ID
- NCT00311896
- Acronym / sponsor ID
- ICT-BEM-2004-02
- Conditions
- Cancer, Thrombosis
- Keywords
- Cancer, Thrombosis, Catheter, Bemiparin, Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped due to difficulties to recruit 402 patients required by protocol
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Laboratorio farmacéutico ROVI
- Study start
- Jul 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Apr 2006 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy and safety of the subcutaneous administration for 45 days of Bemiparin (3,500 UI/day) in cancer patients with a CVC, to prevent CVC-related deep venous thrombosis (CVC-DVT)
Detailed description
Venous thromboembolism (VTE) is a common complication in patients with cancer principally in association with central vein catheters (CVC). The clinical benefit of antithrombotic prophylaxis for CVC-related VTE in cancer patients remains unclear.The aim of this study is to evaluate the efficacy and safety of the administration of Bemiparin in cancer patients with a central venous catheter (CVC). This study is designed as a multicenter, randomized, double-blind, placebo-controlled study. On the day of CVC insertion, eligible patients are randomly assigned to receive subcutaneously either bemiparin (3,500 UI/day) or placebo by using preloaded syringes for 45 days.
The primary efficacy endpoint will be the combined incidence during the double blind treatment period of Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography)and subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bemiparin | Experimental | Drug: Bemiparin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years old of either sex who have given their informed consent to participate in the study.
- Patients with a neoplastic process, with a CVC for the administration of anti-tumoral treatment or any other treatment related to the neoplastic process.
- Patients with a platelet count above 30,000/mm3.
- Patients with no hemorrhagic symptomatology at the time of their inclusion
Key exclusion criteria (15 listed)
- Patients with a history of clinically evident hemorrhagic episodes and/or with increased bleeding due to any other homeostatic alteration that contraindicates anticoagulant treatment and/or in the past two months have presented at least one of the following: active hemorrhaging or organic lesions susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular accident, aneurysms).
- Major surgery in the past two months.
- Known hypersensitivity to LMWH, heparin or substances of porcine origin.
- Patients with congenital or acquired bleeding diathesis.
- Damage to or surgical interventions of the central nervous system, eyes and ears within the past 6 months.
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 |
|---|---|---|
| Bemiparin | Drug | Bemiparin |
| Placebo | Drug | Placebo |
Primary outcome
Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).
Subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
Results and safety
The study was stopped early (reason given: Sponsor stopped due to difficulties to recruit 402 patients required by protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Eduardo Rocha, MD study chair
Clinica Universitaria de Navarra
Ramon Lecumberri, MD principal investigator
Clinica Universitaria de Navarra
Vicente Vicente, MD principal investigator
Hospital Morales Meseguer
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bemiparin in people with Cancer and Thrombosis, run by Clinica Universidad de Navarra, Universidad de Navarra at 19 sites in 2 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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain, Romania. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor stopped due to difficulties to recruit 402 patients required by protocol). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).. 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 8 Jun 2012.