Condition category
Haematological Disorders
Date applied
29/06/2004
Date assigned
22/07/2004
Last edited
15/08/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Crowther

ORCID ID

Contact details

St Joseph's Hospital
Room L 208
50 Charlton Avenue East
Hamilton
Ontario
L8N 4A6
Canada
+1 905 521 6024
crowthrm@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00143715

Protocol/serial number

MCT-66693

Study information

Scientific title

Acronym

Study hypothesis

The objective of this trial is to determine if oral vitamin K reduces the risk of bleeding in patients with warfarin-associated coagulopathy, without causing thrombosis.

Ethics approval

Ethics approval received from McMaster University Research Ethics Board, Hamilton, Ontario (Canada) on the 19th April 2004 (ref: R.P. #04-2327).

Study design

Multicentre, international, two arm, randomised parallel placebo/drug trial with study participant, study investigator, caregiver outcome assessor and data analyst blinded.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Coagulopathy due to warfarin therapy

Intervention

Randomised patients (with INR between 4.5 and 10) will receive either low-dose oral vitamin K, or matching placebo, and will be followed for thrombosis and bleeding outcomes.

Patients with INR greater than 10 (a cohort study), will receive a 2.5 mg dose of oral vitamin K and will be monitored for bleeding and thrombosis.

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin K

Primary outcome measures

Proportion of patients with bleeding in each arm.

Secondary outcome measures

1. Major haemorrhage, or all clinically overt hemorrhage thrombosis and a composite of these two measures
2. Changes in INR values
3. Cost effectiveness

Overall trial start date

01/09/2004

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. 660 patients of either sex
2. Aged 18 and over
3. With International Normalised Ratio (INR) values of 4.5 to 10.0 and for cohort study: patients with INR values greater than 10

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

660 (724 enrolled in RCT and 107 in parallel cohort study as of 19/10/2007)

Participant exclusion criteria

1. Active bleeding
2. Geographic inaccessibility and lack of informed consent
3. Age less than 18 years
4. Warfarin is being discontinued
5. Vitamin K allergy

Recruitment start date

01/09/2004

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Canada, Italy, United States of America

Trial participating centre

St Joseph's Hospital
Hamilton, Ontario
L8N 4A6
Canada

Sponsor information

Organisation

Canadian Institutes of Health Research (CIHR) (Canada)

Sponsor details

Room 97
160 Elgin Street
Address locator: 4809A
Ottawa
Ontario
K1A 0W9
Canada
+1 888 603 4178
info@cihr-irsc.gc.ca

Sponsor type

Research organisation

Website

http://www.cihr-irsc.gc.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-66693)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes