Clinical Trial: Study of Global Coagulation Tests in Patients With Paroxysmal Nocturnal Haemoglobinuria

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: A Pilot Study Investigating the Role of Thrombin Generation and Rotational Thromboelastometry in Assessing the Prothrombotic Phenotype of Paroxysmal Nocturnal Haemaglobinuria

Brief Summary: 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.

Detailed Summary:
Sponsor: King's College Hospital NHS Trust

Current Primary Outcome: To establish the role of thrombin generation in assessing the prothrombotic phenotype of PNH [ Time Frame: After sample is obtained ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To establish the role of thromboelastometry in evaluating the prothrombotic phenotype of PNH [ Time Frame: After sample is obtained ]
  • To establish effects of eculizumab treatment on thrombin generation and thromboelastometry [ Time Frame: 3-6 months ]


Original Secondary Outcome:

  • To establish the role of thromboelastometry in evaluating the prothrombotic phenotype of PNH [ Time Frame: After sample is obtained ]
  • To establish effects of eculizumab treatment on thrombin generation and thromboelastometry [ Time Frame: After sample is obtained ]


Information By: King's College Hospital NHS Trust

Dates:
Date Received: November 20, 2009
Date Started: August 2009
Date Completion: August 2012
Last Updated: May 25, 2010
Last Verified: May 2010