Turkish Acquired Haemophilia Registry

NCT01403740 | Unknown

• 1 other identifier: 2011/HEM/001
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Turkish Acquired Haemophilia Registry is a database in which information about clinical features and therapeutic management of acquired haemophilia is collected in Turkey.This is a multicentre, retrospective and prospective registry of subjects diagnosed and/or treated for acquired haemophilia. Patients will be registered and the response to different therapies, details of each bleeding episode and the outcome of haemostatic and immunosuppressive therapy (IST) will be recorded. Any male or female subject diagnosed with inhibitors to FVIII or other factors and treated for acquired haemophilia can be entered on the registry. Patients will be treated according to local practice. No additional tests or procedures are required by the registry. The retrospective period will not be time-limited and data will be collected from those recorded in the hospital notes. The prospective period will begin in September 1.2011, and will last for two years.

Conditions

Acquired Haemophilia

Keywords

acquired haemophilia; factor VIII

Study Arms (1)

Acquired haemophilia patients

Drug: rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin

Interventions

rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin DRUG

According to local clinical standards

Acquired haemophilia patients

Eligibility Criteria

• 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 acquired haemophilia diagnosed and/or treated in haematology clinics

You may qualify if:

• Acquired haemophilia diagnosis, written consent

You may not qualify if:

• Being unable to give written consent

Sponsors & Collaborators

• Turkish Society of Hematology: lead

Study Sites (1)

Trakya University Haematology Clinic

Edirne, 22030, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for coagulation factor determination

MeSH Terms

Conditions

Hemophilia A

Interventions

Deamino Arginine Vasopressin; Azathioprine; Rituximab; Cyclosporine

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

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Muzaffer A Demir, Prof

  THD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Solakoglu, MD

CONTACT

902123253232; dileksolakoglu@cortexiletisim.com

Volkan Aydin, MD

CONTACT

902123253232; volkanaydin@cortexiletisim.com

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 27, 2011

Record last verified: 2011-06

Locations

TU (1)