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

• ClinicalTrials.gov Identifier: NCT00905229
• Recruitment Status: Withdrawn
• First Posted: May 20, 2009
• Last Update Posted: June 23, 2015
• Sponsor: HaEmek Medical Center, Israel
• Information provided by: HaEmek Medical Center, Israel

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.

Condition or disease	Intervention/treatment	Phase
Bleeding; Complications	Drug: Phytonadione	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: May 2009
• Actual Primary Completion Date: April 2010
• Actual Study Completion Date: April 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: PO (by mouth); 2.5 mg P.O Vitamin K	Drug: Phytonadione; 2.5 mg po; Other Name: vitamin k
Active Comparator: IV (intravenous ); 0.5 mg IV Vitamin K	Drug: Phytonadione; 0.5 mg IV; Other Name: vitamin k

Outcome Measures

Primary Outcome Measures :

1. International normalized ratio (INR) </= 1.2 [ Time Frame: 3 days ]

Secondary Outcome Measures :

1. Bleeding [ Time Frame: 6 weeks ]
2. Complications [ Time Frame: 6 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• hip fracture patients on warfarin

Exclusion Criteria:

• pregnancy
• vitamin k sensitivity

Contacts and Locations

Locations

Israel

Haemek Medical Center

Afula, Israel

Sponsors and Collaborators

HaEmek Medical Center, Israel

More Information

Publications:

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.

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.

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.

• Responsible Party: orit semana, haemek medical center
• ClinicalTrials.gov Identifier: NCT00905229
• Other Study ID Numbers: 02-09
• First Posted: May 20, 2009
• Last Update Posted: June 23, 2015
• Last Verified: June 2015

Keywords provided by HaEmek Medical Center, Israel:

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

Additional relevant MeSH terms:

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Vitamins; Vitamin K; Vitamin K 1; Micronutrients; Physiological Effects of Drugs; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants