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Turkish Acquired Haemophilia Registry (EHEM)

Primary Purpose

Acquired Haemophilia

Status

Unknown status

Phase

Locations

Turkey

Study Type

Observational

Intervention

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

About this trial

This is an observational trial for Acquired Haemophilia focused on measuring acquired haemophilia, factor VIII

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Acquired haemophilia diagnosis, written consent

Exclusion Criteria:

Being unable to give written consent

Sites / Locations

Trakya University Haematology Clinic

Arms of the Study

Arm 1

Arm Type

Arm Label

Acquired haemophilia patients

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01403740

First Posted

July 26, 2011

Last Updated

July 26, 2011

Sponsor

Turkish Society of Hematology

1. Study Identification

Unique Protocol Identification Number

NCT01403740

Brief Title

Turkish Acquired Haemophilia Registry

Acronym

EHEM

Official Title

Observational Acquired Haemophilia Registry

Study Type

Observational

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

August 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Turkish Society of Hematology

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acquired Haemophilia

Keywords

acquired haemophilia, factor VIII

7. Study Design

Enrollment

250 (Anticipated)

Biospecimen Retention

Samples Without DNA

Biospecimen Description

Blood sample for coagulation factor determination

8. Arms, Groups, and Interventions

Arm Title

Acquired haemophilia patients

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

According to local clinical standards

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Acquired haemophilia diagnosis, written consent Exclusion Criteria: Being unable to give written consent

Study Population Description

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

Sampling Method

Non-Probability Sample

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dilek Solakoglu, MD

Phone

902123253232

dileksolakoglu@cortexiletisim.com

First Name & Middle Initial & Last Name or Official Title & Degree

Volkan Aydin, MD

Phone

902123253232

volkanaydin@cortexiletisim.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muzaffer A Demir, Prof

Organizational Affiliation

THD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Trakya University Haematology Clinic

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Muzaffer A Demir, Prof

Phone

902842351041

mdemir@trakya.edu.tr

First Name & Middle Initial & Last Name & Degree

Dilek Solakoglu, MD

Phone

902123253232

dileksolakoglu@cortexiletisim.com

First Name & Middle Initial & Last Name & Degree

Muzaffer A Demir, Prof

12. IPD Sharing Statement

Learn more about this trial

Turkish Acquired Haemophilia Registry

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