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

Bleeding Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00905229
• Other study ID #: 02-09
• Status: Withdrawn
• Phase: N/A
• First received: May 18, 2009
• Last updated: June 21, 2015
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hip fracture patients on warfarin

Exclusion Criteria:

• pregnancy

• vitamin k sensitivity

Study Design

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

Related Conditions & MeSH terms

• Bleeding
• Complications

Intervention

Drug:
• Phytonadione
2.5 mg po
• Phytonadione
0.5 mg IV

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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

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. doi: 10.1378/chest.08-0670. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International normalized ratio (INR) </= 1.2		3 days	No
Secondary	Bleeding		6 weeks	Yes
Secondary	Complications		6 weeks	Yes