Trochanteric Hip FracturesNCT04614090
Fast Reversal of Warfarin and Early Surgery in Patients With Trochanteric Hip Fracture A Case-control Study
An observational study of Trochanteric Hip Fractures and Warfarin Medication, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A retrospective case-control study. To evaluate if early surgery within 24hours of troch or subtrochanteric hip fractures using intramedullary nailing is safe in patients on warfarin treatment after fast reversal of the warfarin effect Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Trochanteric Hip Fractures, Warfarin Medication, Early Surgery
- How many people
- 198 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2017to 26 Jun 2018
- 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 60 years and older
- All sexes
- Adult, Older adult
Study population: Patients on warfarin, with low-energi trauma, >60years, mean 86 years Op at Stockholm South General Hospital (södersjukhuset) between (Jan 1,2011 - Dec 31,2014) Follow-up 1 year, all pat op within 24 hours from hospital arrival to the surgery. Operated with Intramedullary nail due to unstable intertrochanteric (OTA/AO 31A2, A3) or Subtrochanteric fracture (OTA/AO 32A,32B,32C).
Who may be able to join
None listed.
Who cannot join
- Pathological fracture
- Late presentation to the hospital
- Other injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Fast Reversal and Early Surgery (Within 24 h) in Patients on Warfarin Medication With Trochanteric Hip Fractures Safe: A Case-control Study
A retrospective case-control study. To evaluate if early surgery within 24hours of troch or subtrochanteric hip fractures using intramedullary nailing is safe in patients on warfarin treatment after fast reversal of the warfarin effect
- Keywords
- Hip fracture, Surgical treatment, Warfarin, Anticoagulation treatment, Intramedullary nailing
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 99 warfarin patients | warfarin patients were operated within 24 h with a cephalomedullary nail due to a trochanteric or subtrochanteric hip fracture. All patients on warfarin were reversed if necessary to INR≤1.5 before surgery using vitamin K and/or four-factor prothrombin complex concentrate (PCC) | |
| 99 patients without anticoagulants | As a 1:1 ratio control group matched for age, gender and surgical implant. All patients were operated within 24 h with a cephalomedullary nail due to a trochanteric or subtrochanteric hip fracture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion rates
Hb value (g/dl)
Measured: Pre-surgery
Transfusion rates
Transfusion rate (n)
Measured: Pre-surgery
Transfusion rates
Hb value (g/dl)
Measured: During the surgery
Transfusion rates
Transfusion rate (n)
Measured: During the surgery
Transfusion rates
Hb value (g/dl)
Measured: 2-4 days after the surgery
Transfusion rates
Transfusion rate (n)
Measured: 2-4 days after the surgery
adverse events
Number of patients with a myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, sepsis, pneumonia, urinary tract infection, pressure ulcer, or any adverse events.
Measured: Immediately after the surgery
mortality
The number of deaths
Measured: Immediately after the surgery
mortality
The number of deaths
Measured: 30-days after the surgery
mortality
The number of deaths
Measured: 1 year after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Oct 2017
- Primary completion1 Feb 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trochanteric Hip FracturesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Retrospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital
- Responsible party
- Principal investigator, Leif Mattisson, Karolinska Institutet
- Investigators
- Leif Mattisson, Principal investigator, Stockholm South General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614090
- Sponsor's protocol ID
- Leif Mattisson
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
Publications
Mattisson L, Lapidus LJ, Enocson A. Is fast reversal and early surgery (within 24 h) in patients on warfarin medication with trochanteric hip fractures safe? A case-control study. BMC Musculoskelet Disord. 2018 Jun 26;19(1):203. doi: 10.1186/s12891-018-2126-3.
PubMed 29945596
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Fast Reversal and Early Surgery (Within 24 h) in Patients on Warfarin Medication With Trochanteric Hip Fractures Safe: A Case-control Study
- ClinicalTrials.gov ID
- NCT04614090
- Acronym / sponsor ID
- Leif Mattisson
- Keywords
- Hip fracture, Surgical treatment, Warfarin, Anticoagulation treatment, Intramedullary nailing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 3 Nov 2020 (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.
A retrospective case-control study. To evaluate if early surgery within 24hours of troch or subtrochanteric hip fractures using intramedullary nailing is safe in patients on warfarin treatment after fast reversal of the warfarin effect
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 99 warfarin patients | – | –warfarin patients were operated within 24 h with a cephalomedullary nail due to a trochanteric or subtrochanteric hip fracture. All patients on warfarin were reversed if necessary to INR≤1.5 before surgery using vitamin K and/or four-factor prothrombin complex concentrate (PCC) |
| 99 patients without anticoagulants | – | –As a 1:1 ratio control group matched for age, gender and surgical implant. All patients were operated within 24 h with a cephalomedullary nail due to a trochanteric or subtrochanteric hip fracture. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients on warfarin, with low-energi trauma, >60years, mean 86 years Op at Stockholm South General Hospital (södersjukhuset) between (Jan 1,2011 - Dec 31,2014) Follow-up 1 year, all pat op within 24 hours from hospital arrival to the surgery. Operated with Intramedullary nail due to unstable intertrochanteric (OTA/AO 31A2, A3) or Subtrochanteric fracture (OTA/AO 32A,32B,32C).
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Pathological fracture
- Late presentation to the hospital
- Other injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transfusion rates
Time frame: Pre-surgery
Hb value (g/dl)
Transfusion rates
Time frame: Pre-surgery
Transfusion rate (n)
Transfusion rates
Time frame: During the surgery
Hb value (g/dl)
Transfusion rates
Time frame: During the surgery
Transfusion rate (n)
Transfusion rates
Time frame: 2-4 days after the surgery
Hb value (g/dl)
Transfusion rates
Time frame: 2-4 days after the surgery
Transfusion rate (n)
adverse events
Time frame: Immediately after the surgery
Number of patients with a myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, sepsis, pneumonia, urinary tract infection, pressure ulcer, or any adverse events.
mortality
Time frame: Immediately after the surgery
The number of deaths
mortality
Time frame: 30-days after the surgery
The number of deaths
mortality
Time frame: 1 year after the surgery
The number of deaths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Results publication: PubMed 29945596Mattisson L, Lapidus LJ, Enocson A. Is fast reversal and early surgery (within 24 h) in patients on warfarin medication with trochanteric hip fractures safe? A case-control study. BMC Musculoskelet Disord. 2018 Jun 26;19(1):203. doi: 10.1186/s12891-018-2126-3.
Related trials for Trochanteric Hip Fractures
Not yet recruiting
Trochanteric Bursa Repair and Lateral Hip Pain After Hemiarthroplasty for Femoral Neck Fracture
Femoral Neck Fracture
Active, not recruiting
Insignia™ Hip Stem Outcomes Study
Hip Osteoarthritis, Avascular Necrosis
Recruiting
Intramedullary Nail Versus Hip Arthroplasty in Unstable Trochanteric Hip Fractures
Hip Injuries and Disorders, Hip Fractures
Enrolling by invitation
G7 Freedom Constrained Vivacit-E Liners
Osteoarthritis, Hip, Rheumatoid Arthritis
Active, not recruitingObservational study
G7 BiSpherical Acetabular Shell PMCF Study
Rheumatoid Arthritis, Osteoarthritis
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.
Leif Mattisson principal investigator
Stockholm South General Hospital
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 Trochanteric Hip Fractures and Warfarin Medication, run by Karolinska Institutet at 1 site in Sweden.
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 0 inclusion and 3 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: finished, as of the sponsor's last update on 3 Nov 2020. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfusion rates (time frame: Pre-surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614090, which also lists 1 linked publication.
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 3 Nov 2020.