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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905229
First Posted: May 20, 2009
Last Update Posted: June 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
HaEmek Medical Center, Israel
May 18, 2009
May 20, 2009
June 23, 2015
May 2009
April 2010   (Final data collection date for primary outcome measure)
International normalized ratio (INR) </= 1.2 [ Time Frame: 3 days ]
Same as current
Complete list of historical versions of study NCT00905229 on ClinicalTrials.gov Archive Site
  • Bleeding [ Time Frame: 6 weeks ]
  • Complications [ Time Frame: 6 weeks ]
Same as current
Not Provided
Not Provided
 
Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bleeding
  • Complications
  • Drug: Phytonadione
    2.5 mg po
    Other Name: vitamin k
  • Drug: Phytonadione
    0.5 mg IV
    Other Name: vitamin k
  • Active Comparator: PO (by mouth)
    2.5 mg P.O Vitamin K
    Intervention: Drug: Phytonadione
  • Active Comparator: IV (intravenous )
    0.5 mg IV Vitamin K
    Intervention: Drug: Phytonadione

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • hip fracture patients on warfarin

Exclusion Criteria:

  • pregnancy
  • vitamin k sensitivity
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00905229
02-09
Yes
Not Provided
Not Provided
orit semana, haemek medical center
HaEmek Medical Center, Israel
Not Provided
Not Provided
HaEmek Medical Center, Israel
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP