Infections

All Conditions

Heart and Blood Diseases

Neoplasms

Blood and Lymph Conditions

Symptoms and General Pathology

Thrombosis

Hematologic Neoplasms

Communicable Diseases

Bacteremia

Catheter-Related Infections

Embolism

Embolism and Thrombosis

Vascular Diseases

Hematologic Diseases

Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Sepsis

Toxemia

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Other Dietary Supplements

Heparin

Citric Acid

Sodium Citrate

Calcium heparin

Citrate

After each use, the central venous catheter lumen will be flushed with 10 ml 0.9% NaCl and then locked with heparin 5000 IU/ml(standard treatment)using a volume exactly equivalent to the internal volume noted on each catheter.

locking the central venous catheter with concentrated citrate after each use

when not in use CVCs are locked with heparin

heparin

when not in use the CVC is locked with concentrated citrate

concentrated citrate

Harry Schouten, MD

Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used.

The purpose of this study is to determine whether concentrated citrate locking, compared to heparin, reduces the incidence of central venous catheter-related thrombosis and infections in patients with hematological malignancies undergoing intensive chemotherapy.

Central venous catheter (CVC)-related thrombosis and infections are frequently occurring complications and may cause significant morbidity in patients with hematological malignancies. Interventions to decrease fibrin deposition have the potential to reduce CVC-related thrombosis and infections.

At present heparin is most often used as locking solution for central venous catheters in hematological patients despite a lack of evidence regarding the efficacy and safety. Trisodium citrate (TSC) had been shown to be an effective antimicrobial catheter locking in hemodialysis patients.

Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients

Concentrated Citrate Locking to Reduce the Incidence of Central Venous Catheter-related Infections and Thrombosis: a Randomized Phase III Study in a Hematological Patient Population

Patients will be followed from insertion of the central venous catheter till removal of the central venous catheter, an expected average of 30 days. The central venous catheter is seen daily and checked for thrombosis and infections when the patient is admitted on the ward. Discharged patients are seen at least weekly on the outpatients clinic and their central venous catheter is checked for thrombosis and infections. A standard ultrasound is made 30 days after insertion and within 24 hours after removal of the central venous catheter.

Dirinco B.V.

Maastricht University Medical Center

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Thromboembolism

Venous Thromboembolism

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Apixaban

Adult patient, over 18 years old, with newly diagnosed multiple myeloma, indication of chemotherapy.

Peripheral blood sampling will be performed at different time points of the study, for a total volume of 20-40 mL:

* Sampling before MM treatment,
* Sampling during MM treatment (at 3 months post-initiation if no autograft or before autograft),
* Only for Patients treated with Apixaban or Eliquis®, 2 additional samplings during MM treatment for pharmacokinetics analysis.

Blood samples

Emilie Chalayer, MD

Elisabeth Daguenet, PhD

Lionel Karlin, MD

Denis Guyotat, PhD

Ludovic Fouillet, MD

Caroline Lejeune, MD

Karine Augeul-Meunier, MD

Thierry Thomas, PhD

Karima Boussoualim, MD

The association between multiple myeloma (MM) and venous thromboembolism (VTE) is well known. Indeed, the incidence of VTE is increased in patients with newly diagnosed MM and in patients treated by immunomodulatory drugs in combination with glucocorticoids. Moreover, the clinical outcome of MM is supposed to be correlated to the risk of thrombosis. At the biological level, a number of hemostasis abnormalities participate in increasing VTE incidence. Yet, data on predictive biomarkers linked to VTE are limited.

There is a need to discern predictive biomarkers in order to better identify patients at risk of developing VTE, to decipher the mechanisms by which myeloma treatments interfere and in fine to choose an adequate thromboprophylaxis. In this context, it is important to document the precise expression of coagulation factors and to profile point-of-care tests for coagulation monitoring in newly diagnosed MM patients, before and during treatment. In addition, thromboprophylaxis is systematically included in therapeutic MM strategies, especially direct oral anticoagulants, without knowing whether potential drug interactions are occurring. This study aims at evaluating and validating predictive biomarkers of VTE in MM, and at identifying patients whose thromboprophylaxis is required and may potentially be adjusted because of drug interactions.

Biomarkers in Multiple Myeloma

Evaluation of Predictive Biomarkers in de Novo Multiple Myeloma on the Onset of Venous Thromboembolism, Its Impact on Clinical Outcome and Thromboprophylaxis (VESICOM)

Measurement of thrombin on plasma from newly diagnosed MM patients before the initiation of chemotherapy

Measurement of factor VIII on plasma from newly diagnosed MM patients before the initiation of chemotherapy

Measurement of D-Dimers on plasma from newly diagnosed MM patients before the initiation of chemotherapy

Measurement of pro-coagulant phospholipids on plasma from newly diagnosed MM patients before the initiation of chemotherapy

Correlation between the plasma level of biomarkers and clinical data

Plasma level of Apixaban in MM treated patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients	NCT01820962	Hematological M... Bacteremia Thrombosis	heparin concentrated ci...	18 Years -	Maastricht University Medical Center
Biomarkers in Multiple Myeloma	NCT05259553	Hematological P... Newly Diagnosed... Chemotherapy	Blood samples	18 Years -	Centre Hospitalier Universitaire de Saint Etienne
Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients	NCT01820962	Hematological M... Bacteremia Thrombosis	heparin concentrated ci...	18 Years -	Maastricht University Medical Center

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