Hip FracturesNCT05070169
Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation
An observational study of Hip Fractures, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Prospective cohort study on patients with intertrochanteric fractures under direct oral anticoagulation (DOAC) therapy undergoing early surgical fixation (within 24 hours). The primary aim of this study is to evaluate the reduction of the peri operative blood loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Early Surgical Fixation vs. Delayed Surgical Fixation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteAustria
- Study dates
- 15 Oct 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: 140 patients with intertrochanteric fractures with DOAC therapy undergoing surgical fixation: 70 patients will be included prospectively starting with October 2021, 70 patients with a delayed surgical fixation will be included retrospectively within the time frame January 2014- December 2018.
Who may be able to join
- Prospective cohort study:
- Patients with intertrochanteric fractures that need a surgical fixation and under treatment with a DOAC medication
- Control group:
- Patients with intertrochanteric fractures under DOAC medication with a delayed surgical fixation from January 2014 to December 2018 (≥ 48 hours after the trauma)
Who cannot join
- Prospective cohort group:
- patients with multiple fractures
- acute heart failure, kidney and lung failure and
- other concomitant diseases which prevent prompt fixation
- Retrospective cohort group:
- Patients with delayed surgical fixation due to other causes than DOAC medication (e.g. multimorbidity, acute myocardial infarction, acute heart, lung or kidney failure)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Traumatology
Vienna, 1090
Valerie Weihs, MD, 00436505008952, valerie.weihs@meduniwien.ac.at
About this study
Prospective cohort study on patients with intertrochanteric fractures under direct oral anticoagulation (DOAC) therapy undergoing early surgical fixation (within 24 hours). The primary aim of this study is to evaluate the reduction of the peri operative blood loss. The secondary aim is to assess the influence of early surgical fixation of intertrochanteric fractures in patients with DOAC therapy on the 30-day and 1-year mortality. Moreover, the prospective cohort group of patients will be compared with a retrospectively analyzed age-, gender- and fracture-type-matched control group of patients who underwent delayed surgical fixation from January 2014 to December 2018 (≥ 48 hours).
- Conditions
- Hip Fractures
- Being tested
- Early Surgical Fixation vs. Delayed Surgical Fixation
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Surgical Fixation vs. Delayed Surgical FixationProcedure or surgery
Evaluation of the reduction of the peri-operative blood loss in patients undergoing early surgical fixation (within 24 hours) of an intertrochanteric fracture under DOAC therapy compared to a retrospectively enrolled group of patients who underwent delayed surgical fixation (≥48 hours) of an intertrochanteric fracture under DOAC therapy.
| Study group | Role | What they receive |
|---|---|---|
| Early Surgical Fixation | Prospective cohort of patients with intertrochanteric fractures with DOAC (direct oral anticoagulation) therapy undergoing early surgical fixation (within 24 hours). Receives: Procedure: Early Surgical Fixation vs. Delayed Surgical Fixation | |
| Delayed Surgical Fixation | Retrospective control group of patients with intertrochanteric fractures with DOAC medication who underwent delayed surgical fixation (≥48 hours) from January 2014 to December 2018. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the perioperative blood loss
The main objective of this study is the evaluation of the perioperative blood loss in patients with intertrochanteric fractures with DOAC medication treated in a level I trauma center undergoing early surgical fixation (within 24 hours after the trauma). After routine surgical fixation of the fracture, patients will receive blood draws at day 3 according to standardized routinely performed clinical procedures. The perioperative blood loss will be calculated using the "haemoglobin balance method".
Measured: 3 days
Evaluation of the perioperative need for transfusions
The rate of transfusion will be expressed as the percentage of patients who need at least one unit of red blood cells (RBCs) and the total number of transfused RBC units will be recorded. Only perioperative transfusion up to the third post-operative day will be considered.
Measured: 3 days
Secondary outcomes (1)
Coagulation parameters
Coagulation parameters such as plasma DOAC concentrations and Clot Pro analyzes will be measured in accordance with routine clinical practice.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start15 Oct 2021
- Primary completion15 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Valerie Weihs, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070169
- Sponsor's protocol ID
- 1636/2021
- Status last verified
- Nov 2024
- First submitted
- 22 Sep 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation
- ClinicalTrials.gov ID
- NCT05070169
- Acronym / sponsor ID
- 1636/2021
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Oct 2021 (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.
Prospective cohort study on patients with intertrochanteric fractures under direct oral anticoagulation (DOAC) therapy undergoing early surgical fixation (within 24 hours). The primary aim of this study is to evaluate the reduction of the peri operative blood loss. The secondary aim is to assess the influence of early surgical fixation of intertrochanteric fractures in patients with DOAC therapy on the 30-day and 1-year mortality. Moreover, the prospective cohort group of patients will be compared with a retrospectively analyzed age-, gender- and fracture-type-matched control group of patients who underwent delayed surgical fixation from January 2014 to December 2018 (≥ 48 hours).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Surgical Fixation | – | Procedure: Early Surgical Fixation vs. Delayed Surgical FixationProspective cohort of patients with intertrochanteric fractures with DOAC (direct oral anticoagulation) therapy undergoing early surgical fixation (within 24 hours). |
| Delayed Surgical Fixation | – | –Retrospective control group of patients with intertrochanteric fractures with DOAC medication who underwent delayed surgical fixation (≥48 hours) from January 2014 to December 2018. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 140 patients with intertrochanteric fractures with DOAC therapy undergoing surgical fixation: 70 patients will be included prospectively starting with October 2021, 70 patients with a delayed surgical fixation will be included retrospectively within the time frame January 2014- December 2018.
Key inclusion criteria (4 listed)
- Patients with intertrochanteric fractures that need a surgical fixation and under treatment with a DOAC medication
- Patients with intertrochanteric fractures under DOAC medication with a delayed surgical fixation from January 2014 to December 2018 (≥ 48 hours after the trauma)
Key exclusion criteria (6 listed)
- patients with multiple fractures
- acute heart failure, kidney and lung failure and
- other concomitant diseases which prevent prompt fixation
- Patients with delayed surgical fixation due to other causes than DOAC medication (e.g. multimorbidity, acute myocardial infarction, acute heart, lung or kidney failure)
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 |
|---|---|---|
| Early Surgical Fixation vs. Delayed Surgical FixationEvaluation of the reduction of the peri-operative blood loss in patients undergoing early surgical fixation (within 24 hours) of an intertrochanteric fracture under DOAC therapy compared to a retrospectively enrolled group of patients who underwent delayed surgical fixation (≥48 hours) of an intertrochanteric fracture under DOAC therapy. | Procedure or surgery | Early Surgical Fixation |
Primary outcome
Evaluation of the perioperative blood loss
Time frame: 3 days
The main objective of this study is the evaluation of the perioperative blood loss in patients with intertrochanteric fractures with DOAC medication treated in a level I trauma center undergoing early surgical fixation (within 24 hours after the trauma). After routine surgical fixation of the fracture, patients will receive blood draws at day 3 according to standardized routinely performed clinical procedures. The perioperative blood loss will be calculated using the "haemoglobin balance method".
Evaluation of the perioperative need for transfusions
Time frame: 3 days
The rate of transfusion will be expressed as the percentage of patients who need at least one unit of red blood cells (RBCs) and the total number of transfused RBC units will be recorded. Only perioperative transfusion up to the third post-operative day will be considered.
1 secondary outcome
Coagulation parameters
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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.
Medical University of Vienna, Department of Traumatology
Vienna, Austria
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 Hip Fractures, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Nov 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the perioperative blood loss (time frame: 3 days). The study lists 2 primary outcomes in all. 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 25 Nov 2024.