- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00905229
Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery
It is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical intervention is the preferred treatment.
Any delay in operating on such patients would inevitably increase their risk of developing complications. One of the reasons for such unintentional delay would be the hypercoagulative status of patients taking warfarin. The CHEST 2008 guidelines suggest reversing warfarin with Vitamin K for patients who need urgent operation. The aim of this study is to compare different roots and doses of Vitamin K.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Afula, Israel
- HaEmek Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- hip fracture patients on warfarin
Exclusion Criteria:
- pregnancy
- vitamin k sensitivity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PO (by mouth)
2.5 mg P.O Vitamin K
|
2.5 mg po
Other Names:
0.5 mg IV
Other Names:
|
Active Comparator: IV (intravenous )
0.5 mg IV Vitamin K
|
2.5 mg po
Other Names:
0.5 mg IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
International normalized ratio (INR) </= 1.2
Time Frame: 3 days
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complications
Time Frame: 6 weeks
|
6 weeks
|
Bleeding
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):160S-198S. doi: 10.1378/chest.08-0670.
- Al-Rashid M, Parker MJ. Anticoagulation management in hip fracture patients on warfarin. Injury. 2005 Nov;36(11):1311-5. doi: 10.1016/j.injury.2005.05.004.
- Lubetsky A, Yonath H, Olchovsky D, Loebstein R, Halkin H, Ezra D. Comparison of oral vs intravenous phytonadione (vitamin K1) in patients with excessive anticoagulation: a prospective randomized controlled study. Arch Intern Med. 2003 Nov 10;163(20):2469-73. doi: 10.1001/archinte.163.20.2469.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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