Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery

This study is not yet open for participant recruitment.

Verified by HaEmek Medical Center, Israel, May 2009

First Received: May 18, 2009 Last Updated: May 19, 2009 History of Changes

Sponsor:	HaEmek Medical Center, Israel
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00905229

Purpose

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.

Condition	Intervention
Bleeding Complications	Drug: Phytonadione

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Fractures Hip Injuries and Disorders Hip Replacement Surgery

Drug Information available for: Vitamin K1 Vitamin K Warfarin Phytonadione

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

International normalized ratio (INR) </= 1.2 [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bleeding [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Complications [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	May 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PO (by mouth): Active Comparator 2.5 mg P.O Vitamin K	Drug: Phytonadione 2.5 mg po
IV (intravenous ): Active Comparator 0.5 mg IV Vitamin K	Drug: Phytonadione 0.5 mg IV

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

hip fracture patients on warfarin

Exclusion Criteria:

pregnancy
vitamin k sensitivity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905229

Contacts

Contact: guy rubin, M.D

972-4-6494300

guy_ru@clalit.org.il

Locations

Israel
Haemek Medical Center
afula, Israel

Sponsors and Collaborators

HaEmek Medical Center, Israel

More Information

Publications:

Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G; American College of Chest Physicians. 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.

Al-Rashid M, Parker MJ. Anticoagulation management in hip fracture patients on warfarin. Injury. 2005 Nov;36(11):1311-5.

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.

Responsible Party:	haemek medical center ( orit semana )
Study ID Numbers:	02-09
Study First Received:	May 18, 2009
Last Updated:	May 19, 2009
ClinicalTrials.gov Identifier:	NCT00905229 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:

hip fracture
warfarin
vitamin k
Phytonadione
INR level

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Coagulants
Growth Substances
Physiological Effects of Drugs
Hematologic Agents
Vitamin K 1
Pharmacologic Actions

Hemostatics
Fibrin Modulating Agents
Antifibrinolytic Agents
Therapeutic Uses
Vitamins
Vitamin K
Micronutrients

ClinicalTrials.gov processed this record on February 08, 2010