Study of Global Coagulation Tests in Patients With Paroxysmal Nocturnal Haemoglobinuria
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 |
Subjects with paroxysmal nocturnal haemoglobinuria
Inclusion Criteria:
- Presence of a PNH clone
Exclusion Criteria:
- Longterm anticoagulation for previous venous thrombosis
Contacts and Locations| Contact: Dupe Elebute, MB, MD | 02032995761 | dupe.elebute@nhs.net |
| 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 | |
| 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 May 22, 2013