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

May 18, 2009
May 19, 2009
May 2009
May 2011   (final data collection date for primary outcome measure)
International normalized ratio (INR) </= 1.2 [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00905229 on ClinicalTrials.gov Archive Site
  • Bleeding [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Not yet recruiting
60
March 2012
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • hip fracture patients on warfarin

Exclusion Criteria:

  • pregnancy
  • vitamin k sensitivity
Both
18 Years and older
No
Contact: guy rubin, M.D 972-4-6494300 guy_ru@clalit.org.il
Israel
 
NCT00905229
02-09
Yes
orit semana, haemek medical center
HaEmek Medical Center, Israel
Not Provided
Not Provided
HaEmek Medical Center, Israel
May 2009

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