Turkish Acquired Haemophilia Registry (EHEM)
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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 |
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 |
Patients with acquired haemophilia diagnosed and/or treated in haematology clinics
Inclusion Criteria:
- Acquired haemophilia diagnosis, written consent
Exclusion Criteria:
- Being unable to give written consent
Contacts and Locations| Contact: Dilek Solakoglu, MD | 902123253232 | dileksolakoglu@cortexiletisim.com |
| Contact: Volkan Aydin, MD | 902123253232 | volkanaydin@cortexiletisim.com |
| 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 | |
| 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 May 16, 2013