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 August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bleeding; Complications
Intervention: Phytonadione (Drug); Phytonadione (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: HaEmek Medical Center, Israel
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) = 1.2
Secondary outcome: BleedingComplications
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
Haemek Medical Center, Afula, Israel
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. 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. 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: June 21, 2015
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