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

Primary Purpose

Bleeding, Complications

Status

Withdrawn

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Phytonadione

About this trial

This is an interventional treatment trial for Bleeding focused on measuring hip fracture, warfarin, vitamin k, Phytonadione, INR level

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

hip fracture patients on warfarin

Exclusion Criteria:

pregnancy
vitamin k sensitivity

Sites / Locations

Haemek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PO (by mouth)

IV (intravenous )

Arm Description

2.5 mg P.O Vitamin K

0.5 mg IV Vitamin K

Outcomes

Primary Outcome Measures

International normalized ratio (INR) </= 1.2

Secondary Outcome Measures

Bleeding

Complications

Full Information

NCT ID

NCT00905229

First Posted

May 18, 2009

Last Updated

June 21, 2015

Sponsor

HaEmek Medical Center, Israel

1. Study Identification

Unique Protocol Identification Number

NCT00905229

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Enrollment problems

Study Start Date

May 2009 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bleeding, Complications

Keywords

hip fracture, warfarin, vitamin k, Phytonadione, INR level

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PO (by mouth)

Arm Type

Active Comparator

Arm Description

2.5 mg P.O Vitamin K

Arm Title

IV (intravenous )

Arm Type

Active Comparator

Arm Description

0.5 mg IV Vitamin K

Intervention Type

Drug

Intervention Name(s)

Phytonadione

Other Intervention Name(s)

vitamin k

Intervention Description

2.5 mg po

Intervention Type

Drug

Intervention Name(s)

Phytonadione

Other Intervention Name(s)

vitamin k

Intervention Description

0.5 mg IV

Primary Outcome Measure Information:

Title

International normalized ratio (INR) </= 1.2

Time Frame

3 days

Secondary Outcome Measure Information:

Title

Bleeding

Time Frame

6 weeks

Title

Complications

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: hip fracture patients on warfarin Exclusion Criteria: pregnancy vitamin k sensitivity

Facility Information:

Facility Name

Haemek Medical Center

City

Afula

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

18574265

Citation

Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):160S-198S. doi: 10.1378/chest.08-0670.

Results Reference

background

PubMed Identifier

16214475

Citation

Al-Rashid M, Parker MJ. Anticoagulation management in hip fracture patients on warfarin. Injury. 2005 Nov;36(11):1311-5. doi: 10.1016/j.injury.2005.05.004.

Results Reference

background

PubMed Identifier

14609783

Citation

Lubetsky A, Yonath H, Olchovsky D, Loebstein R, Halkin H, Ezra D. Comparison of oral vs intravenous phytonadione (vitamin K1) in patients with excessive anticoagulation: a prospective randomized controlled study. Arch Intern Med. 2003 Nov 10;163(20):2469-73. doi: 10.1001/archinte.163.20.2469.

Results Reference

background

Learn more about this trial

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

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