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

Information source: HaEmek Medical Center, Israel
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bleeding; Complications

Intervention: Phytonadione (Drug); Phytonadione (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: HaEmek Medical Center, Israel

Overall contact:
guy rubin, M.D, Phone: 972-4-6494300, Email: guy_ru@clalit.org.il

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: International normalized ratio (INR) Secondary outcome:

Bleeding

Complications

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- hip fracture patients on warfarin

Exclusion Criteria:

- pregnancy

- vitamin k sensitivity

Locations and Contacts

guy rubin, M.D, Phone: 972-4-6494300, Email: guy_ru@clalit.org.il

Haemek Medical Center, Afula, Israel; Not yet recruiting
guy rubin, M.D, Phone: 972-4-6494300
guy rubin, M.D, Principal Investigator
Additional Information

Related publications:

Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G; American College of Chest Physicians. 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.

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

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.

Starting date: May 2009
Last updated: May 19, 2009

Page last updated: November 27, 2014

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