OsteoperosisNCT06644976
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
An observational study of Osteoperosis and Femoral Neck Fractures, run by Meir Hospital, Kfar Saba, Israel at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoperosis, Femoral Neck Fractures, Anticoagulant Therapy
- What is being tested?
- femoral neck CRIF
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Aug 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with femoral neck fracture thattake noac and arrive at meir hospital and need surgery
Who may be able to join
- above 18 y.o femoral neck fracture NOAC capable of making inform consent primary surgery
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Hospital
Kfar Saba, 4428164
Meron talmor, medical doctor, +972523264183, merontalmor@gmail.com
About this study
Official title: 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
- Conditions
- Osteoperosis, Femoral Neck Fractures, Anticoagulant Therapy
- Being tested
- femoral neck CRIF
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoral neck CRIFProcedure or surgery
femoral neck fracture CRiF while under noac. no special intervention beside taking blood test for drug levels
| Study group | Role | What they receive |
|---|---|---|
| early surgery | Not described Receives: Procedure: femoral neck CRIF | |
| late surgery | Not described Receives: Procedure: femoral neck CRIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start20 Aug 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoperosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Hospital, Kfar Saba, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maron Talmore, Meir Hospital, Kfar Saba, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644976
- Sponsor's protocol ID
- mmc000723
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding of Patients Using NOAC Anticoagulation Therapy in Proximal Femoral Fracture Internal Fixation Surgery
- ClinicalTrials.gov ID
- NCT06644976
- Acronym / sponsor ID
- mmc000723
- Conditions
- Osteoperosis, Femoral Neck Fractures, Anticoagulant Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Hospital, Kfar Saba, IsraelUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early surgery | – | Procedure: femoral neck CRIF |
| late surgery | – | Procedure: femoral neck CRIF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with femoral neck fracture thattake noac and arrive at meir hospital and need surgery
Key inclusion criteria (2 listed)
- above 18 y.o femoral neck fracture NOAC capable of making inform consent primary surgery
- -
Key exclusion criteria (7 listed)
- under 18 y.o
- anti platelet therapy (aspirin is not included)
- creatinine clearance under 50
- active anti cancer therapy
- ITP patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| femoral neck CRIFfemoral neck fracture CRiF while under noac. no special intervention beside taking blood test for drug levels | Procedure or surgery | early surgery, late surgery |
Primary outcome
bleeding
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Osteoperosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoperosis and Femoral Neck Fractures, run by Meir Hospital, Kfar Saba, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meron pinchas talmor, medical doctor (+972523264183, merontalmor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.