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
  Purpose

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.


Condition
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Plasma


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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with paroxysmal nocturnal haemoglobinuria

Criteria

Inclusion Criteria:

  • Presence of a PNH clone

Exclusion Criteria:

  • Longterm anticoagulation for previous venous thrombosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020188

Contacts
Contact: Dupe Elebute, MB, MD 02032995761 dupe.elebute@nhs.net

Locations
United Kingdom
King's College Hospital NHS Trust Recruiting
London, United Kingdom, SE5 9RS
Contact: Dupe Elebute, MB, MD    02032995761    dupe.elebute@nhs.net   
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
Investigators
Principal Investigator: Raj K Patel, MD King's College Hospital NHS Trust
  More Information

No publications provided

Responsible Party: Dr Raj Patel, King's College Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01020188     History of Changes
Other Study ID Numbers: KCH1125
Study First Received: November 20, 2009
Last Updated: May 25, 2010
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Additional relevant MeSH terms:
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Anemia, Hemolytic
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 20, 2014