Turkish Acquired Haemophilia Registry (EHEM)

July 26, 2011 updated by: Turkish Society of Hematology

Observational Acquired Haemophilia Registry

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Edirne, Turkey, 22030
        • Trakya University Haematology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Acquired haemophilia diagnosis, written consent

Exclusion Criteria:

  • Being unable to give written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acquired haemophilia patients
Drug: rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin
According to local clinical standards

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkish Society of Hematology

Investigators

  • Principal Investigator: Muzaffer A Demir, Prof, THD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Estimate)

July 27, 2011

Last Update Submitted That Met QC Criteria

July 26, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/HEM/001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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