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

Not Applicable

Withdrawn

• Conditions: Bleeding; Complications
• Interventions: Drug: Phytonadione

• Registration Number: NCT00905229
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• hip fracture patients on warfarin

Exclusion Criteria

• pregnancy
• vitamin k sensitivity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PO (by mouth)	Phytonadione	2.5 mg P.O Vitamin K
IV (intravenous )	Phytonadione	0.5 mg IV Vitamin K

Primary Outcome Measures

Name	Time	Method
International normalized ratio (INR) </= 1.2	3 days

Secondary Outcome Measures

Name	Time	Method
Bleeding	6 weeks
Complications	6 weeks

Trial Locations

Locations (1)

Haemek Medical Center; 🇮🇱 Afula, Israel