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OpenTrials
Completed

NCT Number: NCT02260414

Effects of Anticoagulant Preventive Injection in Patients With Blood Cancer

In cancer, the incidence of venous thromboembolism (VTE) is particularly high in patients with myeloma, especially when it is de novo and treated with thalidomide, lenalidomide or erythropoietin. Curiously, the prevention of VTE with LMWH (low-molecular-weight heparin) in myeloma seems no more effective than that achieved with aspirin, while the effectiveness of the latter in the primary prevention of VTE has never been demonstrated regardless of the type of population considered. Meanwhile, a biological study showed that prophylactic doses of LMWH in patients with different types of cancer did not always optimal reduction of thrombin peak during the 24 hours following the injection of LMWH. These clinical and biological studies lead to the conclusion that patients with myeloma may be resistant to the usual doses of preventive LMWH, which may explain the failure of prevention.

Initially we intend to investigate whether this resistance to prophylactic doses of LMWH is present in patient's biology and if this resistance is specific to myeloma in hematological cancers. For this, we propose to study the evolution of thrombin generation by Thrombinography during 24 hours after subcutaneous injection of 4500 anti-Xa IU Tinzaparin in 6 patients with de novo myeloma whit high thrombo embolic risk ie treated with thalidomide, lenalidomide or erythropoietin. LMWH is Tinzaparin chosen because it does not accumulate in patients with impaired renal function, and has a greater anti-biological activity thrombotic than other LMWH.

To assess whether the observed pattern of thrombin generation is particularly multiple myeloma, we will take the same study in 6 patients with aggressive lymphoma and 6 medical patients hospitalized for acute heart and respiratory failure.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body weight between 40 and 100 kg
  • Patient:

2a- With multiple myeloma indication with de novo standard treatment thalidomide or lenalidomide or erythropoietin (group 1) 2b- Or hospitalized for aggressive lymphoma treated with chemotherapy (group 2) 2c- Or older than 40 years and hospitalized at least three days for an acute medical pathology type of acute respiratory or cardiac (group 3) decompensation

Exclusion criteria

  • Patient requiring anticoagulant therapy at curative doses
  • Patients with a lower platelet count 80 G / L
  • Subject with a history of heparin-induced thrombocytopenia
  • Subject with a history of hemorrhagic disease
  • History of severe trauma within 6 weeks prior to enrollment
  • Organic lesion at risk of bleeding
  • Poor renal with creatinine clearance <30 ml / min
  • Hypersensitivity to Tinzaparin
  • Events or bleeding tendencies associated with coagulation disorders
  • Subject on oral anticoagulant
  • For group 3: Presence of hematological malignancy or active cancer

Treatment and study plan

tinzaparin

Drug

single subcutaneous injection of 4500 IU tinzaparin

blood sample

Other

blood sample taken at hours 0, 3, 8, 18 and 24 after subcutaneous injection of 4500 IU tinzaparin

Primary outcomes

  1. Endogenous Thrombin Potential (ETP, nM.min) for all patients with de novo myeloma with high thrombotic risk

    Time frame: hours : 0, 3, 8, 18, 24

    Endogenous Thrombin Potential (i.e. the aera under the thrombin generation curve, nM.min) is measured by Thromboplastin Generation Tests (TGTs) following a single injection of 4500 IU tinzaparin

Secondary outcomes

  1. Endogenous Thrombin Potential (ETP, nM.min) for all patients with aggressive lymphoma treated with chemotherapy

    Time frame: hours : 0, 3, 8, 18, 24

    Endogenous Thrombin Potential (i.e. the aera under the thrombin generation curve, nM.min) is measured by Thromboplastin Generation Tests (TGTs) following a single injection of 4500 IU tinzaparin

  2. Endogenous Thrombin Potential (ETP, nM.min) for all patients with over 40 years hospitalized for heart or respiratory failure

    Time frame: hours : 0, 3, 8, 18, 24

    Endogenous Thrombin Potential (i.e. the aera under the thrombin generation curve, nM.min) is measured by Thromboplastin Generation Tests (TGTs) following a single injection of 4500 IU tinzaparin

  3. Differences of Endogenous Thrombin Potential (ETP, nM.min) between group 1 and group 2 et 3

    Time frame: hours : 0, 3, 8, 18, 24

    Endogenous Thrombin Potential (i.e. the aera under the thrombin generation curve, nM.min) is measured by Thromboplastin Generation Tests (TGTs) following a single injection of 4500 IU tinzaparin

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • LEO Pharma

Registry information

Official study title

Effects of Injection Tinzaparin Prophylactic Dose (4,500 IU Anti-Xa) on Thrombin Generation in Patients With Multiple Myeloma, Lymphoma Patients and Patients Hospitalized for an Acute Medical Condition.

Acronym: METRO B

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2014
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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