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

Bleeding of Patients Using NOAC Anticoagulation Therapy in Proximal Femoral Fracture Internal Fixation Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Femoral Neck Fractures; Anticoagulant Therapy; Osteoperosis
• Intervention / Treatment: Procedure: femoral neck CRIF

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Meron pinchas talmor, medical doctor; Phone Number: +972523264183; Email: merontalmor@gmail.com

Study Locations

• Israel
  • Kfar Saba, Israel, 4428164
    • Recruiting
    • Meir Hospital
    • Contact: Meron talmor, medical doctor; Phone Number: +972523264183; Email: merontalmor@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
early surgery	Procedure: femoral neck CRIF; femoral neck fracture CRiF while under noac. no special intervention beside taking blood test for drug levels
late surgery	Procedure: femoral neck CRIF; femoral neck fracture CRiF while under noac. no special intervention beside taking blood test for drug levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
bleeding	30 days

Collaborators and Investigators

• Sponsor: Meir Hospital, Kfar Saba, Israel

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Hip Injuries; Hip Fractures; Femoral Fractures; Hemorrhage; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: mmc000723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No