Turkish Acquired Haemophilia Registry (EHEM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Turkish Society of Hematology.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Turkish Society of Hematology
ClinicalTrials.gov Identifier:
NCT01403740
First received: July 26, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Acquired Haemophilia
Drug: rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin

Study Type: Observational
Official Title: Observational Acquired Haemophilia Registry

Resource links provided by NLM:


Further study details as provided by Turkish Society of Hematology:

Biospecimen Retention:   Samples Without DNA

Blood sample for coagulation factor determination


Estimated Enrollment: 250
Study Start Date: September 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acquired haemophilia patients Drug: rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin
According to local clinical standards

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with acquired haemophilia diagnosed and/or treated in haematology clinics

Criteria

Inclusion Criteria:

  • Acquired haemophilia diagnosis, written consent

Exclusion Criteria:

  • Being unable to give written consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403740

Contacts
Contact: Dilek Solakoglu, MD 902123253232 dileksolakoglu@cortexiletisim.com
Contact: Volkan Aydin, MD 902123253232 volkanaydin@cortexiletisim.com

Locations
Turkey
Trakya University Haematology Clinic Not yet recruiting
Edirne, Turkey, 22030
Contact: Muzaffer A Demir, Prof    902842351041    mdemir@trakya.edu.tr   
Contact: Dilek Solakoglu, MD    902123253232    dileksolakoglu@cortexiletisim.com   
Principal Investigator: Muzaffer A Demir, Prof         
Sponsors and Collaborators
Turkish Society of Hematology
Investigators
Principal Investigator: Muzaffer A Demir, Prof THD
  More Information

Additional Information:
No publications provided

Responsible Party: Turkish Society of Hematology
ClinicalTrials.gov Identifier: NCT01403740     History of Changes
Other Study ID Numbers: 2011/HEM/001
Study First Received: July 26, 2011
Last Updated: July 26, 2011
Health Authority: Turkey: Ministry of Health Drugs and Pharmacy Administration

Keywords provided by Turkish Society of Hematology:
acquired haemophilia
factor VIII

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Azathioprine
Cyclosporins
Cyclosporine
Rituximab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 26, 2014