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

This study has been withdrawn prior to enrollment.
(Enrollment problems)
Information provided by:
HaEmek Medical Center, Israel Identifier:
First received: May 18, 2009
Last updated: June 21, 2015
Last verified: June 2015

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
Drug: Phytonadione

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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 ]

Enrollment: 0
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PO (by mouth)
2.5 mg P.O Vitamin K
Drug: Phytonadione
2.5 mg po
Other Name: vitamin k
Active Comparator: IV (intravenous )
0.5 mg IV Vitamin K
Drug: Phytonadione
0.5 mg IV
Other Name: vitamin k


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

Inclusion Criteria:

  • hip fracture patients on warfarin

Exclusion Criteria:

  • pregnancy
  • vitamin k sensitivity
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Please refer to this study by its identifier: NCT00905229

Haemek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

Responsible Party: orit semana, haemek medical center Identifier: NCT00905229     History of Changes
Other Study ID Numbers: 02-09
Study First Received: May 18, 2009
Last Updated: June 21, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
hip fracture
vitamin k
INR level

Additional relevant MeSH terms:
Vitamin K
Vitamin K 1
Antifibrinolytic Agents
Fibrin Modulating Agents
Growth Substances
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 30, 2015