Monitoring Bleeding of Patients Using NOAC Anticoagulatio... | NCT06644976

Studies
Monitoring Bleeding of Patients Using NOAC Anticoagulation Therapy in Proximal Femoral Fracture Internal Fixation Surgery Without Waiting. We Measure Bleeding in Surgery and the Levels of Noac Drug in Blood. We Will Try to Compare to Regular Pateints Later

NCT06644976

Sponsor

Meir Hospital, Kfar Saba, Israel

Status

Recruiting

Last Update Posted

Oct 16, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Osteoperosis
Femoral Neck Fractures
Anticoagulant Therapy

Interventions

femoral neck CRIF

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

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2024Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Oct 14, 2024

First Submission Date that Met QC Criteria

Oct 14, 2024

First Posted Date

Oct 16, 2024Actual

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

Oct 14, 2024

Last Update Posted Date

Oct 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maron Talmore, Dr. meron pinchas talmor, Meir Hospital, Kfar Saba, IsraelPrincipal Investigator

Lead Sponsor

Meir Hospital, Kfar Saba, IsraelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

until today we waited at least 24 hours before surgery of femoral neck fractures in patients who take anticouagolation . in our new reasearch we belive that patients who take NOAC can go under surgery earlier with minimal risk

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
early surgery			Procedure: femoral neck CRIF
late surgery			Procedure: femoral neck CRIF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
femoral neck CRIF	Procedure	femoral neck fracture CRiF while under noac. no special intervention beside taking blood test for drug levels	early surgery late surgery

Measure	Description	Time Frame
bleeding		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

above 18 y.o femoral neck fracture NOAC capable of making inform consent primary surgery

Exclusion Criteria:

under 18 y.o
anti platelet therapy (aspirin is not included)
creatinine clearance under 50
active anti cancer therapy
ITP patients
non capable of making inform consent
patients which decide not to proceed with the expeirment

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

patients with femoral neck fracture thattake noac and arrive at meir hospital and need surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meron pinchas talmor, medical doctor	Contact	+972523264183		merontalmor@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Hospital	Recruiting	Kfar Saba		4428164	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries
D007869	Leg Injuries