Investigation of Coagulation Parameters in Hereditary Haemorrhagic Telangiectasia

NCT ID: NCT00230659

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-07-31

Brief Summary

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We will address coagulation parameters in hereditary haemorrhagic telangiectasia (HHT) compared to controls.

Detailed Description

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The inherited disease hereditary haemorrhagic telangiectasia (HHT) causes bleeding from dilated fragile vessels, particularly in the nose and gut. However, many HHT patients develop deep venous thromboses and/or pulmonary embolism, necessitating treatments with anticoagulants that further impair control of their haemorrhagic state. Our initial observations using general coagulation tests suggest that the blood of HHT patients is intrinsically hypercoagulable.

We hypothesize that the genetically-determined abnormality in the blood vessels of HHT patients leads to alteration in the concentrations or activity of one or several of the proteins which affect blood clotting leading to a hypercoagulable state.

We propose to study levels and activity of blood coagulation factors in people with hereditary haemorrhagic telangiectasia and in normal volunteers. This should define the significance and basis for our initial observations, and will have significant implications for the clinical management of HHT patients.

Conditions

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Telangiectasia, Hereditary Hemorrhagic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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HHT patients

Patients with hereditary haemorrhagic telangiectasia. Blood sample to be taken.

Blood sample to be taken.

Intervention Type OTHER

Blood sample to be taken.

Controls

People without hereditary haemorrhagic telangiectasia. Blood sample to be taken.

Blood sample to be taken.

Intervention Type OTHER

Blood sample to be taken.

Interventions

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Blood sample to be taken.

Blood sample to be taken.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with HHT and normal controls

Exclusion Criteria

* Previous thrombosis, recent ill health
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hammersmith Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Shovlin

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College Hammersmith Campus

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Shovlin CL, Sulaiman NL, Govani FS, Jackson JE, Begbie ME. Elevated factor VIII in hereditary haemorrhagic telangiectasia (HHT): association with venous thromboembolism. Thromb Haemost. 2007 Nov;98(5):1031-9.

Reference Type RESULT
PMID: 18000608 (View on PubMed)

Livesey JA, Manning RA, Meek JH, Jackson JE, Kulinskaya E, Laffan MA, Shovlin CL. Low serum iron levels are associated with elevated plasma levels of coagulation factor VIII and pulmonary emboli/deep venous thromboses in replicate cohorts of patients with hereditary haemorrhagic telangiectasia. Thorax. 2012 Apr;67(4):328-33. doi: 10.1136/thoraxjnl-2011-201076. Epub 2011 Dec 14.

Reference Type RESULT
PMID: 22169361 (View on PubMed)

Shovlin CL, Chamali B, Santhirapala V, Livesey JA, Angus G, Manning R, Laffan MA, Meek J, Tighe HC, Jackson JE. Ischaemic strokes in patients with pulmonary arteriovenous malformations and hereditary hemorrhagic telangiectasia: associations with iron deficiency and platelets. PLoS One. 2014 Feb 19;9(2):e88812. doi: 10.1371/journal.pone.0088812. eCollection 2014.

Reference Type RESULT
PMID: 24586400 (View on PubMed)

Other Identifiers

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IC/CLS6

Identifier Type: -

Identifier Source: org_study_id

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