Comparing Different Routes and Doses of Phytonadione (Vit... | NCT00905229

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

NCT00905229

Sponsor

HaEmek Medical Center, Israel

Status

Withdrawn

Last Update Posted

Jun 23, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Bleeding
Complications

Interventions

Phytonadione
Phytonadione

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment problems

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

May 18, 2009

First Submission Date that Met QC Criteria

May 19, 2009

First Posted Date

May 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2015

Last Update Posted Date

Jun 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Phytonadione	Drug	2.5 mg po	PO (by mouth)	vitamin k

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
International normalized ratio (INR) </= 1.2		3 days

Secondary Outcomes

Measure	Description	Time Frame
Bleeding		6 weeks
Complications		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hip fracture patients on warfarin

Exclusion Criteria:

pregnancy
vitamin k sensitivity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18574265	Background	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.
16214475	Background

ID	Term
D006470	Hemorrhage
D006620	Hip Fractures

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D005264	Femoral Fractures
D050723	Fractures, Bone

ID	Term
D010837	Vitamin K 1
D014812	Vitamin K

ID	Term
D009285	Naphthoquinones
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic