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

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ClinicalTrials.gov Identifier: NCT02324517
Recruitment Status : Unknown
Verified December 2014 by Prof. Gila Kenet MD, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : December 24, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Gila Kenet MD, Sheba Medical Center

Brief Summary:
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.

Condition or disease
Severe Hemophilia

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders, Including Hemophilia With Inhibitors
Study Start Date : March 2010
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Hemophilia
Patients with Hemophilia A OR B
inhibitor patients
Hemophilia or FXI def with inhibitors
anticoagulants
patients under therapy with various anticoagulant drugs
thrombocytopenia
patients with ITP, chronic thrombocytopenia, chemotherapy induced thrombocytopenia
platelet function disorders
Glanzmann, Bernard Soulier, antiplatelet therapy
Fibrinogen disordsers
hyperfibrinogenemia, hypofibrinogenemia, dysfibrinogenemia
acquired hemophilia
patients with autoimmune Ab's to FVIII
RBD
FXIII DEF, FV+FVIII DEF, FVII DEF, FV DEF
THROMBOLYTICS
Patients treated by thrombolytic agents
Hypercoag
thrombophilias, thrombosis- inc under therapy, acquired high thrombotic risk (eg: cancer)



Primary Outcome Measures :
  1. Thrombin Generation Parameters pre and post therapy / spiking assays [ Time Frame: 1 year from enrollment ]
    Thrombin Generation Parameters (Peak height, ETP) before and after spiking assays with procoagulant drugs will be compared for each patient separately and within each group of patients diagnosed with similar coagulation disorder.



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Ages Eligible for Study:   6 Months to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with coagulopathies (see brief description)
Criteria

Inclusion Criteria:

  • Informed consent
  • Validated coagulation disorder

Exclusion Criteria:

  • Not consenting to participate
  • Multiple coagulopathies and comorbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324517


Contacts
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Contact: Gili Kenet, MD +972526666385 gili.kenet@sheba.health.gov.il

Locations
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Israel
Sheba Mediacl Center Recruiting
Ramat Gan, Israel, 52621
Contact: GITA VEIBER       Gita.veiber@sheba.health.gov.il   
Principal Investigator: Gili Kenet, MD         
Sponsors and Collaborators
Sheba Medical Center

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Responsible Party: Prof. Gila Kenet MD, Director- Thrombosis Unit, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02324517     History of Changes
Other Study ID Numbers: SHEBA-09-7563-GK-CTIL
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014

Keywords provided by Prof. Gila Kenet MD, Sheba Medical Center:
response to various potential therapies as managed by lab assays

Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Anticoagulants