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

NCT02324517 | Unknown

• 1 other identifier: SHEBA-09-7563-GK-CTIL
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Hemophilia

Keywords

response to various potential therapies as managed by lab assays

Outcome Measures

Primary Outcomes (1)

• Thrombin Generation Parameters pre and post therapy / spiking assays

  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.

  1 year from enrollment

Study Arms (10)

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)

Eligibility Criteria

• Age: 6 Months - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with coagulopathies (see brief description)

You may qualify if:

• Informed consent
• Validated coagulation disorder

You may not qualify if:

• Not consenting to participate
• Multiple coagulopathies and comorbidities

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Mediacl Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Gili Kenet, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director- Thrombosis Unit

Study Record Dates

• First Submitted: November 30, 2014
• First Posted: December 24, 2014
• Study Start: March 1, 2010
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

IL (1)