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

S

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)

Trial contacts and locations

1

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Central trial contact

Gili Kenet, MD

Data sourced from clinicaltrials.gov

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