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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00905229
First received: May 18, 2009
Last updated: May 19, 2009
Last verified: May 2009
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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
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

  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 Not yet recruiting
Afula, Israel
Contact: guy rubin, M.D     972-4-6494300        
Principal Investigator: guy rubin, M.D            
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

Publications:

Responsible Party: orit semana, haemek medical center
ClinicalTrials.gov Identifier: NCT00905229     History of Changes
Other Study ID Numbers: 02-09
Study First Received: May 18, 2009
Last Updated: May 19, 2009
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:
Hemorrhage
Hip Fractures
Pathologic Processes
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Vitamin K 1
Vitamin K
Vitamins
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013