Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders

Sheba Medical Center

Status: Unknown

Conditions: Severe Hemophilia

Study type: Observational

Funder types: Other

Identifiers

NCT02324517

SHEBA-09-7563-GK-CTIL

Details and patient eligibility

About

Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. In this study blood sampled from patients with bleeding disorders will be evaluated applying ex- vivo spiking assays with various coagulation concentrates to potentially address the feasibility of replacement /bypass agents/ combined therapy for future bleeding episodes. Patients that will be further treated by any regimen potentially suggested (as standard care- not within trial) will be thereafter followed , including repeated lab studies to assess the impact of therapy upon hemostasis.

Enrollment: 300 estimated patients

Sex: All

Ages: 6 months to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent
• Validated coagulation disorder

Exclusion criteria

• Not consenting to participate
• Multiple coagulopathies and comorbidities

Trial design

300 participants in 10 patient groups

Hemophilia

Description:

Patients with Hemophilia A OR B

inhibitor patients

Description:

Hemophilia or FXI def with inhibitors

anticoagulants

Description:

patients under therapy with various anticoagulant drugs

thrombocytopenia

Description:

patients with ITP, chronic thrombocytopenia, chemotherapy induced thrombocytopenia

platelet function disorders

Description:

Glanzmann, Bernard Soulier, antiplatelet therapy

Fibrinogen disordsers

Description:

hyperfibrinogenemia, hypofibrinogenemia, dysfibrinogenemia

acquired hemophilia

Description:

patients with autoimmune Ab's to FVIII

RBD

Description:

FXIII DEF, FV+FVIII DEF, FVII DEF, FV DEF

THROMBOLYTICS

Description:

Patients treated by thrombolytic agents

Hypercoag

Description:

thrombophilias, thrombosis- inc under therapy, acquired high thrombotic risk (eg: cancer)