Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Von Willebrand in Ireland Cohort Study (LOVIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03167320
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
James O'Donnell, St. James's Hospital, Ireland

Tracking Information
First Submitted Date April 6, 2016
First Posted Date May 25, 2017
Last Update Posted Date March 28, 2019
Study Start Date October 2014
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2017)
Number of Irish patients with Low Von Willebrand Factor with abnormal bleeding scores [ Time Frame: at enrolment ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03167320 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 23, 2017)
  • The number of patients with Low VWF with abnormal plasma VWF clearance [ Time Frame: 2 years ]
    For each individual enrolled the Von Willebrand factor propeptide (VWF:pp, U/dL), Von Willebrand factor antigen (VWF:Ag IU/dL) and Factor VIII:C (FVIII:C IU/dL) levels at enrolment will be determined. From this data the plasma VWF clearance will be ascertained using the plasma VWF:pp/VWF:Ag ratio. In addition, the FVIII:C/VWF:Ag ratio will be calculated to determine the contribution of altered VWF synthesis to Low VWF.
  • The rate of response to DDAVP in Irish patients with low Von Willebrand factor levels [ Time Frame: 3 years ]
    For each individual with no contraindication a DDAVP trial will be performed with plasma VWF levels taken pre and at 1 and 4 hours post DDAVP. The rate of plasma VWF level fall off for each trial will be determined and the area under the curve (AUC) calculated. Complete response will be defined as a three fold increase from baseline.
  • The number of patients with Low VWF with reduced plasma VWF synthesis [ Time Frame: 3 years ]
    For each individual enrolled the Von Willebrand factor antigen (VWF:Ag IU/dL) and Factor VIII:C (FVIII:C IU/dL) levels at enrolment will be determined. From this data the plasma FVIII:C/VWF:Ag ratio will be calculated to determine the contribution of altered VWF synthesis to Low VWF.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Low Von Willebrand in Ireland Cohort Study
Official Title Low Von Willebrand in Ireland Cohort Study
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.
Detailed Description

All patients with bleeding disorders in Ireland are registered on a national bleeding disorder database and attend the National Coagulation Centre in St. James's Hospital, Dublin, Ireland or the paediatric centre, Our Lady's Children's Hospital Crumlin for annual review. At review eligible patients will be invited to participate in the Low Von Willebrand in Ireland Cohort (LOVIC) study.

Following consent, an extensive bleeding assessment tool will be administered by a coagulation haematologist to all participants from which the International Society of Thrombosis and Haemostasis Bleeding Assessment Tool (ISTH BAT) and the Condensed Molecular and Clinical Markers for the Diagnosis and Management of Type 1 Von Willebrands Disease (MCMDM-1 VWD) scores can be derived. In addition, blood will be drawn for von Willebrand factor (VWF) measurements, VWF propeptide, platelet VWF. Citrated plasma and DNA will be stored for each patient. The relationship between laboratory parameters, (including von Willebrand factor, platelet VWF, FVIII and concomitant coagulation disorders) and the clinical phenotype in patients with low VWF will be studied. We will assess the effect of the laboratory parameters on the severity of bleeding tendency. In the future mutation analysis of the VWF gene will be performed in all participants in the LOVIC study.

Historical patient records and laboratory results will be reviewed and DDAVP (1-desamino-8-D-arginine vasopressin) fall off studies documented where available. If no previous DDAVP fall off study has been performed patients will be invited to attend.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Peripheral venous blood samples will be taken at study enrolment and stored for further analysis, including samples for DNA analysis.
Sampling Method Non-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.
Condition Von Willebrand Factor, Deficiency
Intervention Not Provided
Study Groups/Cohorts 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 29, 2019)
400
Original Estimated Enrollment
 (submitted: May 23, 2017)
200
Estimated Study Completion Date July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant patients
  • Hospitalised patients/acutely unwell patients
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Michelle Lavin, FRCPath +35314162141 nchcd@stjames.ie
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03167320
Other Study ID Numbers LOVIC01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party James O'Donnell, St. James's Hospital, Ireland
Study Sponsor St. James's Hospital, Ireland
Collaborators Not Provided
Investigators
Principal Investigator: James S O'Donnell, MD,PhD St. James's Hospital, Dublin Ireland
PRS Account St. James's Hospital, Ireland
Verification Date March 2019