Study of Global Coagulation Tests in Patients With Paroxysmal Nocturnal Haemoglobinuria

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by King's College Hospital NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01020188
First received: November 20, 2009
Last updated: May 25, 2010
Last verified: May 2010

November 20, 2009
May 25, 2010
August 2009
August 2012   (final data collection date for primary outcome measure)
To establish the role of thrombin generation in assessing the prothrombotic phenotype of PNH [ Time Frame: After sample is obtained ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01020188 on ClinicalTrials.gov Archive Site
  • To establish the role of thromboelastometry in evaluating the prothrombotic phenotype of PNH [ Time Frame: After sample is obtained ] [ Designated as safety issue: No ]
  • To establish effects of eculizumab treatment on thrombin generation and thromboelastometry [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
  • To establish the role of thromboelastometry in evaluating the prothrombotic phenotype of PNH [ Time Frame: After sample is obtained ] [ Designated as safety issue: No ]
  • To establish effects of eculizumab treatment on thrombin generation and thromboelastometry [ Time Frame: After sample is obtained ] [ Designated as safety issue: No ]
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Not Provided
 
Study of Global Coagulation Tests in Patients With Paroxysmal Nocturnal Haemoglobinuria
A Pilot Study Investigating the Role of Thrombin Generation and Rotational Thromboelastometry in Assessing the Prothrombotic Phenotype of Paroxysmal Nocturnal Haemaglobinuria

Paroxysmal nocturnal haemaoglobinuria (PNH) is a rare disease which results in breakdown of the red blood cells and bone marrow failure. It is associated with an increased risk of blood clots. Until recently, treatment has been with blood transfusions and in patients with a blood clot, blood thinners. A new treatment called eculizumab is now standard for patients who require regular blood transfusions. It works in the majority of patients by preventing the breakdown of red blood cells. This can eliminate the need for blood transfusion and reduce the risk of blood clots. It is not well understood why patients with PNH are at high risk of blood clots. The investigators plan to use specialised blood tests to assess the stickiness of the blood before starting eculizumab treatment and monthly after starting treatment. The investigators will compare these tests with standard tests of clotting.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma

Non-Probability Sample

Subjects with paroxysmal nocturnal haemoglobinuria

Paroxysmal Nocturnal Haemoglobinuria
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of a PNH clone

Exclusion Criteria:

  • Longterm anticoagulation for previous venous thrombosis
Both
18 Years and older
No
Contact: Dupe Elebute, MB, MD 02032995761 dupe.elebute@nhs.net
United Kingdom
 
NCT01020188
KCH1125
Yes
Dr Raj Patel, King's College Hospital NHS Foundation Trust
King's College Hospital NHS Trust
Not Provided
Principal Investigator: Raj K Patel, MD King's College Hospital NHS Trust
King's College Hospital NHS Trust
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP