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

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ClinicalTrials.gov Identifier: NCT00905229
Recruitment Status : Withdrawn (Enrollment problems)
First Posted : May 20, 2009
Last Update Posted : June 23, 2015
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Brief Summary:

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 or disease Intervention/treatment Phase
Bleeding Complications Drug: Phytonadione Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. International normalized ratio (INR) </= 1.2 [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Bleeding [ Time Frame: 6 weeks ]
  2. Complications [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hip fracture patients on warfarin

Exclusion Criteria:

  • pregnancy
  • vitamin k sensitivity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905229


Locations
Israel
Haemek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel

Publications:
Responsible Party: orit semana, haemek medical center
ClinicalTrials.gov Identifier: NCT00905229     History of Changes
Other Study ID Numbers: 02-09
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Vitamins
Vitamin K
Vitamin K 1
Warfarin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants