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Trial record 14 of 55 for:    "paroxysmal nocturnal hemoglobinuria"

Study of Global Coagulation Tests in Patients With Paroxysmal Nocturnal Haemoglobinuria

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by King's College Hospital NHS Trust.
Recruitment status was:  Recruiting
Information provided by:
King's College Hospital NHS Trust Identifier:
First received: November 20, 2009
Last updated: May 25, 2010
Last verified: May 2010
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.

Paroxysmal Nocturnal Haemoglobinuria

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study Investigating the Role of Thrombin Generation and Rotational Thromboelastometry in Assessing the Prothrombotic Phenotype of Paroxysmal Nocturnal Haemaglobinuria

Resource links provided by NLM:

Further study details as provided by King's College Hospital NHS Trust:

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

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with paroxysmal nocturnal haemoglobinuria

Inclusion Criteria:

  • Presence of a PNH clone

Exclusion Criteria:

  • Longterm anticoagulation for previous venous thrombosis
  Contacts and Locations
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Please refer to this study by its identifier: NCT01020188

Contact: Dupe Elebute, MB, MD 02032995761

United Kingdom
King's College Hospital NHS Trust Recruiting
London, United Kingdom, SE5 9RS
Contact: Dupe Elebute, MB, MD    02032995761   
Principal Investigator: Raj K Patel, MD         
Sub-Investigator: Lara N Roberts, MBBS         
Sub-Investigator: Dupe Elebute, MB, MD         
Sub-Investigator: Roopen Arya, PhD         
Sponsors and Collaborators
King's College Hospital NHS Trust
Principal Investigator: Raj K Patel, MD King's College Hospital NHS Trust
  More Information

Responsible Party: Dr Raj Patel, King's College Hospital NHS Foundation Trust Identifier: NCT01020188     History of Changes
Other Study ID Numbers: KCH1125
Study First Received: November 20, 2009
Last Updated: May 25, 2010

Additional relevant MeSH terms:
Hemoglobinuria, Paroxysmal
Anemia, Hemolytic
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms processed this record on May 25, 2017