Does low dose oral vitamin K reduce the risk of bleeding, without causing thrombosis, in patients with warfarin-associated coagulopathy: a randomised clinical trial
| ISRCTN | ISRCTN16632843 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16632843 |
| ClinicalTrials.gov number | NCT00143715 |
| Secondary identifying numbers | MCT-66693 |
- Submission date
- 29/06/2004
- Registration date
- 22/07/2004
- Last edited
- 31/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mark Crowther
Scientific
Scientific
St Joseph's Hospital
Room L 208
50 Charlton Avenue East
Hamilton, Ontario
L8N 4A6
Canada
| Phone | +1 905 521 6024 |
|---|---|
| crowthrm@mcmaster.ca |
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Does low dose oral vitamin K reduce the risk of bleeding, without causing thrombosis, in patients with warfarin-associated coagulopathy: a randomised clinical trial |
| Study objectives | 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(s) | Ethics approval received from McMaster University Research Ethics Board, Hamilton, Ontario (Canada) on the 19th April 2004 (ref: R.P. #04-2327). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2004 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 660 (724 enrolled in RCT and 107 in parallel cohort study as of 19/10/2007) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Canada
- Italy
- United States of America
Study participating centre
St Joseph's Hospital
Hamilton, Ontario
L8N 4A6
Canada
L8N 4A6
Canada
Sponsor information
Canadian Institutes of Health Research (CIHR) (Canada)
Research organisation
Research organisation
Room 97, 160 Elgin Street
Address locator: 4809A
Ottawa, Ontario
K1A 0W9
Canada
| Phone | +1 888 603 4178 |
|---|---|
| info@cihr-irsc.gc.ca | |
| Website | http://www.cihr-irsc.gc.ca/ |
"ROR" |
https://ror.org/01gavpb45 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-66693)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/03/2009 | 31/01/2019 | Yes | No |
Editorial Notes
31/01/2019: Publication reference added
