NeoplasmsaXaNCT02898051
Anti Xa Activity in Cancer Patients Receiving Low-molecular-weight Heparin for Venous Thromboembolism
An observational study of Neoplasms and Venous Thromboembolism, run by Assistance Publique - Hôpitaux de Paris at 8 sites in France.
Trial summary
Low molecular weight heparins (LMWH) are the reference molecule for the long term treatment of venous thromboembolism (VTE) in cancer patients but remains, however, associated with a high risk of recurrent thromboembolism. The high rate of recurrence may result from alterations in the pharmacokinetics of LMWH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Venous Thromboembolism
- How many people
- 370 participants
- Where
- 8 sitesFrance
- Study dates
- Aug 2011to Jan 2018
- 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: Hospitalized patients in tertiary care hospitals participating to the study and treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism (VTE).
Who may be able to join
- Case:
- Being affiliated to a social security scheme
- Having an active solid or hematological cancer (myeloma or lymphoma), histologically or cytologically confirmed, for which the active state will be defined by the existence of a tumoral active disease or an incomplete tumoral resection or the persistence of high tumor markers after complete resection of the tumor.
- The venous thromboembolism disease has to be:
- A deep vein thrombosis of lower extremity (proximal or distal) confirmed by the lack of compressibility of a venous segment under the ultrasound probe or the presence of a venous gap in CT venography or phlebography;
- or a thrombosis of the vena cava or the iliac vein confirmed by an abdominal CT scan with contrast or a venous ultrasound or an ilio-cavography;
Show all 17Show fewer
- or a pulmonary embolism confirmed according to the guidelines of the European Society of Cardiology : through a gap in a pulmonary artery, at least segmental or multiple gaps sub-segmental on spiral CT angiography of the pulmonary arteries or by a high appearance probability on a lung radionuclide imaging, or by clinical symptoms of pulmonary embolism accompanying symptomatic proximal vein thrombosis confirmed by a venous ultrasound or by an unexplained echocardiography acute pulmonary heart in presence of a high clinical probability and for patients who are unfit for transport and with cardiogenic shock
- The venous thromboembolism disease can be asymptomatic or incidentally discovered but is confirmed objectively.
- No cons-indication to low molecular weight heparin treatment at therapeutic dose.
- Prescription in the last 72 hours of a low molecular weight heparin treatment or fondaparinux at therapeutic dose.
- Control:
- Being affiliated to a social security scheme.
- Being free from malignant tumor pathology detectable at the time of inclusion.
- Being afflicted with venous thromboembolism defined by the same criteria of cancer subjects.
- The venous thromboembolism disease can be asymptomatic or incidentally discovered but is confirmed objectively.
- No cons-indication to low molecular weight heparin treatment at therapeutic dose.
- Prescription in the last 72 hours of a low molecular weight heparin treatment or fondaparinux at therapeutic dose.
Who cannot join
- Case:
- Visceral vein thrombosis of the upper limb or venous thrombosis of the superior vena cava system because their scalability under treatment, including the risk of embolic recurrence is less known that pulmonary embolism and thrombosis of the lower limbs and their diagnostic modalities are less formalized.
- Tumor disease not confirmed histologically or cytologically.
- Follow-up after complete tumor resection without elevated tumor markers.
- Cons-indication to low molecular weight heparin treatment at therapeutic dose.
- Initial treatment with another anticoagulant molecule than LMWH or fondaparinux (thrombin inhibitor, direct factor Xa inhibitors)
Show all 18Show fewer
- Severe renal impairment defined by a creatinine clearance below than 30 ml / min at baseline.
- Known pregnancy or lack of effective contraception for women of childbearing age or breastfeeding.
- Patient previously included in the study.
- Impossible follow-up.
- Life expectancy less than 6 months.
- Patient whose weight is greater than 100 Kg.
- Control:
- Not yet confirmed suspected malignant tumor pathology associated with the venous thromboembolism disease.
- Active cancer in the last 2 years.
- Cons-indication to low molecular weight heparin treatment at therapeutic dose.
- Initial treatment with another anticoagulant molecule than LMWH or fondaparinux (thrombin inhibitor, direct factor Xa inhibitors)
- Severe renal impairment defined by a creatinine clearance below than 30 ml / min at baseline.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Amiens - Hôpital Sud
Amiens, Picardie, 80054
Hôpital La Cavale Blanche
Brest, Brittany Region, 29609
Hôpital Louis Mourier
Colombes, Île-de-France Region, 92700
CHU de Dijon
Dijon, Bourgogne-Franche-Comté, 21079
Hôpital d'instruction des armees Desgenettes
Lyon, Auvergne-Rhône-Alpes, 69003
Hôpital Saint-Louis
Paris, Île-de-France Region, 75010
Hôpital Europeen Georges Pompidou
Paris, Île-de-France Region, 75015
CHU de Saint-Etienne Hôpital Nord
Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, 42270
About this study
Low molecular weight heparins (LMWH) are the reference molecule for the long term treatment of venous thromboembolism (VTE) in cancer patients but remains, however, associated with a high risk of recurrent thromboembolism. The high rate of recurrence may result from alterations in the pharmacokinetics of LMWH. The primary purpose of the study is to compare the pharmacokinetics of anti-Xa activity in patients with cancer and patients without cancer treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism (VTE). The secondary purposes are 1/ to study the correlation between anti-Xa LMWH and concentration of plasma heparanase and 2/ to evaluate the predictive nature of the anti-Xa activity on the occurrence of thromboembolic recurrence in cancer patients treated with LMWH for VTE.
Read the detailed description
Purpose of the study:
The primary purpose of the study is to compare the pharmacokinetics of anti-Xa activity in patients with cancer and patients without cancer treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism (VTE).
The secondary purposes are 1/ to study the correlation between anti-Xa LMWH and concentration of plasma heparanase and 2/ to evaluate the predictive nature of the anti-Xa activity on the occurrence of thromboembolic recurrence in cancer patients treated with LMWH for VTE.
Study design:
Multicentre cohort study of patients hospitalized with VTE:
- Observational case-control study to compare the pharmacodynamics of anti-Xa activity between patients cancer patients (n = 50) and non-cancer patients (n = 50) matched (1-1) for age, renal function and LMWH
- A prospective cohort study including 320 cancer patients with a 6 months follow-up.
Study hypothesis:
Venous thrombosis and pulmonary embolism are a common complication of cancer. They complicate up to 10% of cancers and are the cause of fatality, morbidity and significant impaired quality of life. The treatment of these diseases is difficult in this context. Low molecular weight heparins (LMWH) are the reference molecule for the long term treatment of venous thromboembolism (VTE) in cancer patients. Outside this context, their pharmacological properties allow to administer a fixed dose without measuring anti-Xa activity. In the presence of cancer, their use remains, however, associated with a high risk of recurrent thromboembolism up to 9% after 6 months of treatment.
This high rate of recurrence may result from alterations in the pharmacokinetics of LMWH in the presence of a cancer. The synthesis of heparanase by tumor cells might cause a decrease in anti-Xa activity of LMWH and reduce their effectiveness. If this hypothesis is verified, it could result in a change in the management of thrombosis in cancer patients and lead to a dose adjustment of LMWH through the measurement of anti-Xa activity, which may allow reduce the incidence of thromboembolic relapses during treatment.
Enrollment (Target or Actual Number of Subjects):
- Pharmacokinetics study In a preliminary unpublished study of 37 cancer and non-cancer subjects with the highest concentration of anti-Xa activity was measured. Included 100 subjects (50 cancer patients and 50 non-cancer) would detect a maximum level difference of anti-Xa activity in plasma of 0.20 between cancer patients and cancer-with a power of 90% and a risk of the first kind 5%. A difference of 0.20 seems relevant from these preliminary data (median 0.46 vs 0.65), and returns to show that a cancer patient has over 70% chance of having a maximum concentration of anti-Xa activity below that of a free cancer patient (nonparametric Wilcoxon test).
- Cohort study (cancer patients) The risk of recurrent thromboembolism was estimated between 5 and 10% in cancer patients. By including 200 subjects, around twenty events would be observed and corresponds to a reasonable number of subjects can be recruited over 18 months (50 would already enroll in the pharmacodynamic study). The event rate will be assessed on the first 100 patients that will have been followed for 6 months, if event rate is lower than expected, the number of participants will be reassessed.
After over 2 years of inclusion, the event rate is lower than expected (7%). The number of subjects required was therefore reassessed. To reach the number of 20 events necessary to our analysis, a total of 320 cancer subjects must therefore be included.
Target Follow-Up, duration :
Study duration: 5 years and 6 months (inclusion: 5 years follow-up: 6 months). Duration of participation: 3 a 10 days for non-cancer patients, 6 months for cancer patient.
Performance of the study:
- Pharmacokinetics study Inclusion (as soon as the diagnosis is confirmed VTE): 1 tube of blood taken before the start of treatment (at the time of another blood sample) for determination of heparanase. After the start of treatment: 3 tubes of blood drawn for determination of anti-Xa activity. Assays will be centrally performed, blinded from the clinical data and from the group knowledge of the group patient.
- Prospective cohort study of cancer patients Followed for 6 months with consultation at 1, 3, and 6 months (normal monitoring).
Follow-up visits: Collection of clinical data (recurrent thromboembolism, hemorrhage, death, tumor progression, cancer treatment since last visit, interruption of treatment with LMWH, thrombocytopenia, anemia), and removal of 1 tube of blood (at the time of a another sample) for determination of anti-Xa activity.
Thromboembolic recurrences will be validated centrally by an independent committee.
Prospects:
Reduce the incidence of thromboembolic recurrence in cancer patients treated with LMWH for VTE by adapting the dose of LMWH with anti-Xa activity in this population if the hypothesis is verified.
- Conditions
- Neoplasms, Venous Thromboembolism
- Keywords
- heparin low-molecular-weight;pharmacokinetics
- Medical subject headings
- Neoplasms, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Venous Thromboembolism and cancer | Patients hospitalized for Venous Thromboembolism and having a cancer. Inclusion (as soon as the diagnosis of venous thromboembolism is confirmed). One tube of blood taken before the start of treatment (at the time of another blood sample) for determination of heparanase. After the start of treatment: three tubes of blood drawn for determination of anti-Xa activity. Assays will be centrally performed, blinded from the clinical data and from the group knowledge of the group patient. | |
| Venous Thromboembolism and non cancer | Patients hospitalized for Venous Thromboembolism and not having a cancer. Inclusion (as soon as the diagnosis of venous thromboembolism is confirmed). One tube of blood taken before the start of treatment (at the time of another blood sample) for determination of heparanase. After the start of treatment: 3 tubes of blood drawn for determination of anti-Xa activity. Assays will be centrally performed, blinded from the clinical data and from the group knowledge of the group patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-Xa activity
The measurement of anti-Xa activity will be performed four times during the initial treatment for each patient (or during the first 5 to 10 days of treatment) and will establish pharmacokinetic modeling (population type approach, nonlinear model mixed-effect) of the low molecular weight heparin therapy in subjects with cancer or not. In order to obtain a curve of relevant anti-Xa activity.
Measured: 10 days
Secondary outcomes (3)
hemorrhage
Major hemorrhage:
- hemorrhage at the origin of death;
- symptomatic hemorrhage in a major organ such as intracranial hemorrhage, intra spinal, intraocular, retro peritoneal, intra-articular, pericardial and muscle bleeding causing a compartment syndrome
- symptomatic hemorrhage causing a fall in hemoglobin of at least 2 g / dL or leading to a transfusion of at least two blood units.
Other hemorrhage will be considered as non-major.
Measured: 6 months
all cause mortality
Cause and date of death.
The death will be classified as follows:
- related to cancer;
- secondary to bleeding;
- secondary to a confirmed pulmonary embolism;
- other cause;
- unexplained sudden death that can be attributed to pulmonary embolism.
Measured: 6 months
thromboembolic recurrences
All thromboembolic events diagnosed during the follow-up period will be considered in the analysis, whether symptomatic or discovered incidentally on radiographic examination for another reason, evaluation of tumor progression in particular. The recurrence of venous thrombosis should be confirmed objectively by the presence of a non-compressible venous segment in an initially compressible area or by the appearance of a new gap in the CT venography.
The recurrence of pulmonary embolism must be confirmed by the appearance of a gap in a normal artery on the initial scanner or the more proximal extension of thrombosis on the 2nd scanner or the appearance of a segmental perfusion defect without abnormality of ventilation in an initially normal part on the initial scintigraphy or the initial scan.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startAug 2011
- Primary completionOct 2017
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Guy Meyer, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898051
- Sponsor's protocol ID
- P100127
- Other IDs
- PHRC10_02-54, 2011-000154-36
- Acronym
- aXa
- Status last verified
- Oct 2017
- First submitted
- 1 Sep 2016
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chew HK, Wun T, Harvey D, Zhou H, White RH. Incidence of venous thromboembolism and its effect on survival among patients with common cancers. Arch Intern Med. 2006 Feb 27;166(4):458-64. doi: 10.1001/archinte.166.4.458.
PubMed 16505267Khorana AA, Streiff MB, Farge D, Mandala M, Debourdeau P, Cajfinger F, Marty M, Falanga A, Lyman GH. Venous thromboembolism prophylaxis and treatment in cancer: a consensus statement of major guidelines panels and call to action. J Clin Oncol. 2009 Oct 10;27(29):4919-26. doi: 10.1200/JCO.2009.22.3214. Epub 2009 Aug 31.
PubMed 19720907Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):454S-545S. doi: 10.1378/chest.08-0658.
PubMed 18574272Lee AY, Levine MN, Baker RI, Bowden C, Kakkar AK, Prins M, Rickles FR, Julian JA, Haley S, Kovacs MJ, Gent M; Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003 Jul 10;349(2):146-53. doi: 10.1056/NEJMoa025313.
PubMed 12853587Katz BZ, Muhl L, Zwang E, Ilan N, Herishanu Y, Deutsch V, Naparstek E, Vlodavsky I, Preissner KT. Heparanase modulates heparinoids anticoagulant activities via non-enzymatic mechanisms. Thromb Haemost. 2007 Dec;98(6):1193-9.
PubMed 18064313
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti Xa Activity in Cancer Patients Receiving Low-molecular-weight Heparin for Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT02898051
- Acronym / sponsor ID
- aXa / P100127
- Conditions
- Neoplasms, Venous Thromboembolism
- Keywords
- heparin low-molecular-weight;pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France, National Cancer Institute, France
- Study start
- Aug 2011 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jan 2018 (estimated)
- First posted
- 13 Sep 2016 (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.
Low molecular weight heparins (LMWH) are the reference molecule for the long term treatment of venous thromboembolism (VTE) in cancer patients but remains, however, associated with a high risk of recurrent thromboembolism. The high rate of recurrence may result from alterations in the pharmacokinetics of LMWH. The primary purpose of the study is to compare the pharmacokinetics of anti-Xa activity in patients with cancer and patients without cancer treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism (VTE). The secondary purposes are 1/ to study the correlation between anti-Xa LMWH and concentration of plasma heparanase and 2/ to evaluate the predictive nature of the anti-Xa activity on the occurrence of thromboembolic recurrence in cancer patients treated with LMWH for VTE.
Detailed description
Purpose of the study:
The primary purpose of the study is to compare the pharmacokinetics of anti-Xa activity in patients with cancer and patients without cancer treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism (VTE).
The secondary purposes are 1/ to study the correlation between anti-Xa LMWH and concentration of plasma heparanase and 2/ to evaluate the predictive nature of the anti-Xa activity on the occurrence of thromboembolic recurrence in cancer patients treated with LMWH for VTE.
Study design:
Multicentre cohort study of patients hospitalized with VTE:
- Observational case-control study to compare the pharmacodynamics of anti-Xa activity between patients cancer patients (n = 50) and non-cancer patients (n = 50) matched (1-1) for age, renal function and LMWH
- A prospective cohort study including 320 cancer patients with a 6 months follow-up.
Study hypothesis:
Venous thrombosis and pulmonary embolism are a common complication of cancer. They complicate up to 10% of cancers and are the cause of fatality, morbidity and significant impaired quality of life. The treatment of these diseases is difficult in this context. Low molecular weight heparins (LMWH) are the reference molecule for the long term treatment of venous thromboembolism (VTE) in cancer patients. Outside this context, their pharmacological properties allow to administer a fixed dose without measuring anti-Xa activity. In the presence of cancer, their use remains, however, associated with a high risk of recurrent thromboembolism up to 9% after 6 months of treatment.
This high rate of recurrence may result from alterations in the pharmacokinetics of LMWH in the presence of a cancer. The synthesis of heparanase by tumor cells might cause a decrease in anti-Xa activity of LMWH and reduce their effectiveness. If this hypothesis is verified, it could result in a change in the management of thrombosis in cancer patients and lead to a dose adjustment of LMWH through the measurement of anti-Xa activity, which may allow reduce the incidence of thromboembolic relapses during treatment.
Enrollment (Target or Actual Number of Subjects):
- Pharmacokinetics study In a preliminary unpublished study of 37 cancer and non-cancer subjects with the highest concentration of anti-Xa activity was measured. Included 100 subjects (50 cancer patients and 50 non-cancer) would detect a maximum level difference of anti-Xa activity in plasma of 0.20 between cancer patients and cancer-with a power of 90% and a risk of the first kind 5%. A difference of 0.20 seems relevant from these preliminary data (median 0.46 vs 0.65), and returns to show that a cancer patient has over 70% chance of having a maximum concentration of anti-Xa activity below that of a free cancer patient (nonparametric Wilcoxon test).
- Cohort study (cancer patients) The risk of recurrent thromboembolism was estimated between 5 and 10% in cancer patients. By including 200 subjects, around twenty events would be observed and corresponds to a reasonable number of subjects can be recruited over 18 months (50 would already enroll in the pharmacodynamic study). The event rate will be assessed on the first 100 patients that will have been followed for 6 months, if event rate is lower than expected, the number of participants will be reassessed.
After over 2 years of inclusion, the event rate is lower than expected (7%). The number of subjects required was therefore reassessed. To reach the number of 20 events necessary to our analysis, a total of 320 cancer subjects must therefore be included.
Target Follow-Up, duration :
Study duration: 5 years and 6 months (inclusion: 5 years follow-up: 6 months). Duration of participation: 3 a 10 days for non-cancer patients, 6 months for cancer patient.
Performance of the study:
- Pharmacokinetics study Inclusion (as soon as the diagnosis is confirmed VTE): 1 tube of blood taken before the start of treatment (at the time of another blood sample) for determination of heparanase. After the start of treatment: 3 tubes of blood drawn for determination of anti-Xa activity. Assays will be centrally performed, blinded from the clinical data and from the group knowledge of the group patient.
- Prospective cohort study of cancer patients Followed for 6 months with consultation at 1, 3, and 6 months (normal monitoring).
Follow-up visits: Collection of clinical data (recurrent thromboembolism, hemorrhage, death, tumor progression, cancer treatment since last visit, interruption of treatment with LMWH, thrombocytopenia, anemia), and removal of 1 tube of blood (at the time of a another sample) for determination of anti-Xa activity.
Thromboembolic recurrences will be validated centrally by an independent committee.
Prospects:
Reduce the incidence of thromboembolic recurrence in cancer patients treated with LMWH for VTE by adapting the dose of LMWH with anti-Xa activity in this population if the hypothesis is verified.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venous Thromboembolism and cancer | – | –Patients hospitalized for Venous Thromboembolism and having a cancer. Inclusion (as soon as the diagnosis of venous thromboembolism is confirmed). One tube of blood taken before the start of treatment (at the time of another blood sample) for determination of heparanase. After the start of treatment: three tubes of blood drawn for determination of anti-Xa activity. Assays will be centrally performed, blinded from the clinical data and from the group knowledge of the group patient. |
| Venous Thromboembolism and non cancer | – | –Patients hospitalized for Venous Thromboembolism and not having a cancer. Inclusion (as soon as the diagnosis of venous thromboembolism is confirmed). One tube of blood taken before the start of treatment (at the time of another blood sample) for determination of heparanase. After the start of treatment: 3 tubes of blood drawn for determination of anti-Xa activity. Assays will be centrally performed, blinded from the clinical data and from the group knowledge of the group patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients in tertiary care hospitals participating to the study and treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism (VTE).
Key inclusion criteria (17 listed)
- Being affiliated to a social security scheme
- Having an active solid or hematological cancer (myeloma or lymphoma), histologically or cytologically confirmed, for which the active state will be defined by the existence of a tumoral active disease or an incomplete tumoral resection or the persistence of high tumor markers after complete resection of the tumor.
- The venous thromboembolism disease has to be:
- A deep vein thrombosis of lower extremity (proximal or distal) confirmed by the lack of compressibility of a venous segment under the ultrasound probe or the presence of a venous gap in CT venography or phlebography;
- or a thrombosis of the vena cava or the iliac vein confirmed by an abdominal CT scan with contrast or a venous ultrasound or an ilio-cavography;
Key exclusion criteria (18 listed)
- Visceral vein thrombosis of the upper limb or venous thrombosis of the superior vena cava system because their scalability under treatment, including the risk of embolic recurrence is less known that pulmonary embolism and thrombosis of the lower limbs and their diagnostic modalities are less formalized.
- Tumor disease not confirmed histologically or cytologically.
- Follow-up after complete tumor resection without elevated tumor markers.
- Cons-indication to low molecular weight heparin treatment at therapeutic dose.
- Initial treatment with another anticoagulant molecule than LMWH or fondaparinux (thrombin inhibitor, direct factor Xa inhibitors)
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
anti-Xa activity
Time frame: 10 days
The measurement of anti-Xa activity will be performed four times during the initial treatment for each patient (or during the first 5 to 10 days of treatment) and will establish pharmacokinetic modeling (population type approach, nonlinear model mixed-effect) of the low molecular weight heparin therapy in subjects with cancer or not. In order to obtain a curve of relevant anti-Xa activity.
3 secondary outcomes
hemorrhage
Time frame: 6 months
all cause mortality
Time frame: 6 months
thromboembolic recurrences
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Background: PubMed 16505267Chew HK, Wun T, Harvey D, Zhou H, White RH. Incidence of venous thromboembolism and its effect on survival among patients with common cancers. Arch Intern Med. 2006 Feb 27;166(4):458-64. doi: 10.1001/archinte.166.4.458.
- Background: PubMed 19720907Khorana AA, Streiff MB, Farge D, Mandala M, Debourdeau P, Cajfinger F, Marty M, Falanga A, Lyman GH. Venous thromboembolism prophylaxis and treatment in cancer: a consensus statement of major guidelines panels and call to action. J Clin Oncol. 2009 Oct 10;27(29):4919-26. doi: 10.1200/JCO.2009.22.3214. Epub 2009 Aug 31.
- Background: PubMed 18574272Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):454S-545S. doi: 10.1378/chest.08-0658.
- Background: PubMed 12853587Lee AY, Levine MN, Baker RI, Bowden C, Kakkar AK, Prins M, Rickles FR, Julian JA, Haley S, Kovacs MJ, Gent M; Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003 Jul 10;349(2):146-53. doi: 10.1056/NEJMoa025313.
- Background: PubMed 18064313Katz BZ, Muhl L, Zwang E, Ilan N, Herishanu Y, Deutsch V, Naparstek E, Vlodavsky I, Preissner KT. Heparanase modulates heparinoids anticoagulant activities via non-enzymatic mechanisms. Thromb Haemost. 2007 Dec;98(6):1193-9.
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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.
Guy Meyer, MD principal investigator
Assistance Publique - Hôpitaux de Paris
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Venous Thromboembolism, run by Assistance Publique - Hôpitaux de Paris at 8 sites in France.
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 17 inclusion and 18 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
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?
anti-Xa activity (time frame: 10 days). 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 NCT02898051, which also lists 5 linked publications.
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 19 Oct 2017.