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

Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders, Including Hemophilia With Inhibitors

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02324517

Enrollment

300

Registered

2014-12-24

Start date

2010-03-31

Completion date

2017-06-30

Last updated

2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Hemophilia

Keywords

response to various potential therapies as managed by lab assays

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 90 Years

Healthy volunteers

Inclusion criteria

* Informed consent * Validated coagulation disorder

Exclusion criteria

* Not consenting to participate * Multiple coagulopathies and comorbidities

Design outcomes

Primary

Measure	Time frame	Description
Thrombin Generation Parameters pre and post therapy / spiking assays	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.

Countries

Israel

Contacts

Primary ContactGili Kenet, MD

gili.kenet@sheba.health.gov.il+972526666385

Outcome results