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

NCT00905229 | Withdrawn DMC

• 1 other identifier: 02-09
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• International normalized ratio (INR) </= 1.2

  3 days

Secondary Outcomes (2)

• Bleeding

  6 weeks

• Complications

  6 weeks

Study Arms (2)

PO (by mouth)

ACTIVE COMPARATOR

2.5 mg P.O Vitamin K

Drug: Phytonadione

IV (intravenous )

ACTIVE COMPARATOR

0.5 mg IV Vitamin K

Drug: Phytonadione

Interventions

Phytonadione DRUG

2.5 mg po

Also known as: vitamin k

PO (by mouth)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hip fracture patients on warfarin

You may not qualify if:

• pregnancy
• vitamin k sensitivity

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

Related Publications (3)

• 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.

  PMID: 18574265 BACKGROUND

• 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.

  PMID: 16214475 BACKGROUND

• 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.

  PMID: 14609783 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Hip Fractures

Interventions

Vitamin K 1; Vitamin K

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

IL (1)