NCT00230659

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

September 29, 2005

Last Update Submit

September 25, 2023

Conditions

Study Arms (2)

HHT patients

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

Other: Blood sample to be taken.

Controls

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

Other: Blood sample to be taken.

Interventions

Blood sample to be taken.

ControlsHHT patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

'Patients with HHT' have a clinical diagnosis of hereditary haemorrhagic telangiectasia (HHT) 'Normal controls' have NO clinical diagnosis of hereditary haemorrhagic telangiectasia (HHT), and are not blood relatives of someone with HHT."

You may qualify if:

  • Patients with HHT and normal controls

You may not qualify if:

  • Previous thrombosis, recent ill health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Hammersmith Campus

London, W12 0NN, United Kingdom

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma sample aliquots.

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Claire Shovlin

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2005

First Posted

October 3, 2005

Study Start

August 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2008

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations