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

NCT ID: NCT02324517

Last Updated: 2014-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Hemophilia

Keywords

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response to various potential therapies as managed by lab assays

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemophilia

Patients with Hemophilia A OR B

No interventions assigned to this group

inhibitor patients

Hemophilia or FXI def with inhibitors

No interventions assigned to this group

anticoagulants

patients under therapy with various anticoagulant drugs

No interventions assigned to this group

thrombocytopenia

patients with ITP, chronic thrombocytopenia, chemotherapy induced thrombocytopenia

No interventions assigned to this group

platelet function disorders

Glanzmann, Bernard Soulier, antiplatelet therapy

No interventions assigned to this group

Fibrinogen disordsers

hyperfibrinogenemia, hypofibrinogenemia, dysfibrinogenemia

No interventions assigned to this group

acquired hemophilia

patients with autoimmune Ab's to FVIII

No interventions assigned to this group

RBD

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

No interventions assigned to this group

THROMBOLYTICS

Patients treated by thrombolytic agents

No interventions assigned to this group

Hypercoag

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* Validated coagulation disorder

Exclusion Criteria

* Not consenting to participate
* Multiple coagulopathies and comorbidities
Minimum Eligible Age

6 Months

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Gila Kenet MD

Director- Thrombosis Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Mediacl Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Gili Kenet, MD

Role: CONTACT

Phone: +972526666385

Email: [email protected]

Facility Contacts

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GITA VEIBER

Role: primary

Other Identifiers

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SHEBA-09-7563-GK-CTIL

Identifier Type: -

Identifier Source: org_study_id