Effects of Anticoagulant Preventive Injection in Patients With Blood Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02260414
• Date of registration: 02/10/2014
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Public title: Effects of Anticoagulant Preventive Injection in Patients With Blood Cancer METRO B
• Scientific 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.
• Date of first enrolment: April 14, 2015
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02260414
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Bernard TARDY, PhD
• Affiliation: CHU SAINT-ETIENNE

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Body weight between 40 and 100 kg

2. 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lymphoma

Multiple Myeloma

Intervention(s)

Other: Blood sample

Drug: Tinzaparin

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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 (ETP, nM.min) for all patients with aggressive lymphoma treated with chemotherapy [Time Frame: hours : 0, 3, 8, 18, 24]

Secondary ID(s)

2014-000946-31

1408049

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

LEO Pharma