NCT03167320

Brief Summary

The Low Von Willebrand in Ireland Cohort (LoVIC) study focuses on the bleeding phenotype and biological mechanisms underlying low Von Willebrand Factor (VWF) levels.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2016

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

7.8 years

First QC Date

April 6, 2016

Last Update Submit

March 26, 2019

Conditions

Von Willebrand Factor, Deficiency

Outcome Measures

Primary Outcomes (1)

  • Number of Irish patients with Low Von Willebrand Factor with abnormal bleeding scores

    The ISTH-BAT and Condensed MCMDM-1 VWD score of all participants will be determined at enrollment using a physician directed questionnaire using only symptoms prior to their diagnosis with Low VWF. This will help elucidate the bleeding phenotype, if any, associated with Low VWF.

    at enrolment

Secondary Outcomes (3)

  • The number of patients with Low VWF with abnormal plasma VWF clearance

    2 years

  • The rate of response to DDAVP in Irish patients with low Von Willebrand factor levels

    3 years

  • The number of patients with Low VWF with reduced plasma VWF synthesis

    3 years

Study Arms (1)

LOVIC

Irish patients with low Von Willebrand levels will be have both venous blood sampling and a bleeding score administered at study entry. A DDAVP (1-desamino-8-D-arginine vasopressin) fall off study was organised for those patients in the cohort with no previous fall offs available and no contraindications to DDAVP.

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals (adults/children \>3 years) with low Von Willebrand Factor (VWF) levels; defined as two lowest VWF levels (VWF Antigen and/or VWF Ristocetin cofactor activity and/or VWF Collagen Binding) \>30 IU/dL \<50 IU/dL.

You may qualify if:

  • Two lowest VWF levels (VWF Antigen and/or VWF Ristocetin cofactor activity and/or VWF Collagen Binding) \>30 IU/dL \<50 IU/dL.

You may not qualify if:

  • Pregnant patients
  • Hospitalised patients/acutely unwell patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. James's Hospital

Dublin, D8, Ireland

RECRUITING

Related Publications (4)

  • Doherty D, Michelle Lavin, Byrne M, Nolan M, O'Sullivan JM, Ryan K, O'Connell NM, Haberichter SL, Christopherson PA, Di Paola J, James PD, O'Donnell JS. Enhanced VWF clearance in low VWF pathogenesis: limitations of the VWFpp/VWF:Ag ratio and clinical significance. Blood Adv. 2023 Feb 14;7(3):302-308. doi: 10.1182/bloodadvances.2022007340.

    PMID: 35523118DERIVED

  • Aguila S, Lavin M, Dalton N, Patmore S, Chion A, Trahan GD, Jones KL, Keenan C, Brophy TM, O'Connell NM, Ryan K, Byrne M, Nolan M, Patel A, Preston RJS, James P, Di Paola J, O'Sullivan JM, O'Donnell JS. Increased galactose expression and enhanced clearance in patients with low von Willebrand factor. Blood. 2019 Apr 4;133(14):1585-1596. doi: 10.1182/blood-2018-09-874636. Epub 2019 Feb 15.

    PMID: 30770394DERIVED

  • Lavin M, Aguila S, Dalton N, Nolan M, Byrne M, Ryan K, White B, O'Connell NM, O'Sullivan JM, Di Paola J, James PD, O'Donnell JS. Significant gynecological bleeding in women with low von Willebrand factor levels. Blood Adv. 2018 Jul 24;2(14):1784-1791. doi: 10.1182/bloodadvances.2018017418.

    PMID: 30042144DERIVED

  • Lavin M, Aguila S, Schneppenheim S, Dalton N, Jones KL, O'Sullivan JM, O'Connell NM, Ryan K, White B, Byrne M, Rafferty M, Doyle MM, Nolan M, Preston RJS, Budde U, James P, Di Paola J, O'Donnell JS. Novel insights into the clinical phenotype and pathophysiology underlying low VWF levels. Blood. 2017 Nov 23;130(21):2344-2353. doi: 10.1182/blood-2017-05-786699. Epub 2017 Sep 15.

    PMID: 28916584DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood samples will be taken at study enrolment and stored for further analysis, including samples for DNA analysis.

MeSH Terms

Conditions

Von willebrand factor, deficiency

Study Officials

  • James S O'Donnell, MD,PhD

    St. James's Hospital, Dublin Ireland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Lavin, FRCPath

CONTACT

+35314162141nchcd@stjames.ie

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
George Gabriel Stokes Professor of Haematology, Director Haemostasis Research Group

Study Record Dates

First Submitted

April 6, 2016

First Posted

May 25, 2017

Study Start

October 1, 2014

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

IE(1)