Actively Recruiting
Bleeding of Patients Using NOAC Anticoagulation Therapy in Proximal Femoral Fracture Internal Fixation Surgery
Led by Meir Hospital, Kfar Saba, Israel · Updated on 2024-10-16
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with femoral neck fractures who are taking NOAC (novel oral anticoagulants) therapy to see if they can safely undergo surgery sooner than the usual 24-hour wait period. The study aims to monitor bleeding during surgery and measure NOAC drug levels in the blood. It compares patients who have early surgery to those who have surgery later to evaluate bleeding risks. The research involves a procedure called femoral neck closed reduction internal fixation (CRIF) performed while patients are still under NOAC therapy. There are no special interventions beyond taking blood tests to measure drug levels. Two study groups include those receiving early surgery and those undergoing later surgery. Participants will be adults over 18 years with femoral neck fractures on NOAC therapy who can give informed consent. Researchers will monitor bleeding over 30 days following surgery and measure drug levels in the blood. The study is observational, led by Meir Hospital in Israel, and does not involve healthy volunteers. The total study duration and specific visit schedules are not detailed but focus on surgery outcomes and safety.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Femoral neck fracture
- Currently taking NOAC anticoagulant therapy
- Able to provide informed consent
- Scheduled for primary surgery
You will not qualify if you...
- Under 18 years of age
- Receiving anti-platelet therapy (aspirin allowed)
- Creatinine clearance under 50
- Undergoing active anti-cancer therapy
- Diagnosed with immune thrombocytopenic purpura (ITP)
- Unable to provide informed consent
- Declined to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 30 days
Participants undergo proximal femoral fracture internal fixation surgery while on NOAC anticoagulation therapy. Bleeding during surgery and NOAC drug levels in blood are measured.
1 surgery visit and multiple post-operative blood tests
Trial Site Locations
Total: 1 location
1
Meir Hospital
Kfar Saba, Israel, 4428164
Actively Recruiting
Research Team
M
Meron pinchas talmor, medical doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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