Hip FractureNCT02391883
Hip-Fracture Surgery on Patients in Clopidogrel Therapy
An observational study of Hip Fracture, run by Hvidovre University Hospital.
Trial summary
Patients in Clopidogrel therapy alone or in combination with acetylsalicylic acid (Dual Antiplatelet Therapy (DAPT) presenting with a hip-fracture represent the surgeon with the dilemma of putting the patient at risk of a major blood loss during and after surgery, or putting the patient at risk of a thromboembolic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Clopidogrel
- How many people
- 356 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Feb 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 356 patients were included in the final analysis. Out of this group we identified 36 patients taking Clopidogrel. 24 of these were in DAPT. 12 patients were in Clopidogrel therapy alone. The indications for treatment were: CNS thrombosis (n=14); Unstable Angina (n=8); Peripheral Atherosclerosis (n=3); Myocardial Infarction (n=2); Insertion of stent >24 months earlier (n=1); and Unknown indication (n=8). All patients had their treatment discontinued on admission. All analyzed patients were operated within 24 hours of admission (n=356).
Who may be able to join
- All patients operated with short intramedullary nail for hip-fractures, in the study period. (1st of Jan. 2011-31st of Dec. 2013)
Who cannot join
- patients operated >24 hours after admission, patients in other forms of anticoagulation medication except acetylsalicylic acid (including vitamin K antagonists, dipyridamole, dabigatran, apixaban and rivaroxaban), missing data on blood loss in patient chart, missing blood samples in the first 4 days and extra-national patients (follow up not possible). Patients operated on both sides during the inclusion period were only included with data on their latest operation.
About this study
Patients in Clopidogrel therapy alone or in combination with acetylsalicylic acid (Dual Antiplatelet Therapy (DAPT) presenting with a hip-fracture represent the surgeon with the dilemma of putting the patient at risk of a major blood loss during and after surgery, or putting the patient at risk of a thromboembolic event after surgery. The investigators hypothesize that the risk of a major blood loss in patients that are still under the effect of Clopidogrel or DAPT during or after hip-fracture surgery is relatively low. The investigators have conducted a retrospective observational study on hip-fracture patients to test this hypothesis.
- Conditions
- Hip Fracture
- Being tested
- Clopidogrel
- Keywords
- clopidogrel therapy, platelet aggregation inhibitor, adverse event
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Patients in Clopidogrel or Dual Antiplatelet Therapy (Clopidogrel+Acetylsalicylic acid) at the time of admission AND who are operated <24 hours after admission. Receives: Drug: Clopidogrel | |
| Control | Patients NOT in anticoagulation treatment (Except acetylsalicylic acid) AND who are operated <24 hours after admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Blood Loss
Blood loss as assessed by the surgeon
Measured: at time of surgery
Secondary outcomes (4)
Total BLood Loss
Calculated based on the method described by Foss et al 2006 (Hidden Blood Loss in hip fractures)
Measured: From admission to third day after surgery.
Number of transfusions
Number of Red Blood Cell transfusions
Measured: From admission to third day after surgery
30 and 90 day mortality
Recorded from national persons registry (CPR-registeret)
Measured: 30 and 90 days postoperatively
Massive transfusion
>10 Red Blood Cell transfusion within 24 hours of surgery.
Measured: within 24 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- Retrospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Toft Tengberg, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391883
- Sponsor's protocol ID
- CLOP-HIPFX study
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip-Fracture Surgery on Patients in Clopidogrel Therapy
- ClinicalTrials.gov ID
- NCT02391883
- Acronym / sponsor ID
- CLOP-HIPFX study
- Conditions
- Hip Fracture
- Keywords
- clopidogrel therapy, platelet aggregation inhibitor, adverse event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Mar 2015 (estimated)
- 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.
Patients in Clopidogrel therapy alone or in combination with acetylsalicylic acid (Dual Antiplatelet Therapy (DAPT) presenting with a hip-fracture represent the surgeon with the dilemma of putting the patient at risk of a major blood loss during and after surgery, or putting the patient at risk of a thromboembolic event after surgery. The investigators hypothesize that the risk of a major blood loss in patients that are still under the effect of Clopidogrel or DAPT during or after hip-fracture surgery is relatively low. The investigators have conducted a retrospective observational study on hip-fracture patients to test this hypothesis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | – | Drug: ClopidogrelPatients in Clopidogrel or Dual Antiplatelet Therapy (Clopidogrel+Acetylsalicylic acid) at the time of admission AND who are operated <24 hours after admission. |
| Control | – | –Patients NOT in anticoagulation treatment (Except acetylsalicylic acid) AND who are operated <24 hours after admission. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 356 patients were included in the final analysis. Out of this group we identified 36 patients taking Clopidogrel. 24 of these were in DAPT. 12 patients were in Clopidogrel therapy alone. The indications for treatment were: CNS thrombosis (n=14); Unstable Angina (n=8); Peripheral Atherosclerosis (n=3); Myocardial Infarction (n=2); Insertion of stent >24 months earlier (n=1); and Unknown indication (n=8). All patients had their treatment discontinued on admission. All analyzed patients were operated within 24 hours of admission (n=356).
Key inclusion criteria (1 listed)
- All patients operated with short intramedullary nail for hip-fractures, in the study period. (1st of Jan. 2011-31st of Dec. 2013)
Key exclusion criteria (1 listed)
- patients operated >24 hours after admission, patients in other forms of anticoagulation medication except acetylsalicylic acid (including vitamin K antagonists, dipyridamole, dabigatran, apixaban and rivaroxaban), missing data on blood loss in patient chart, missing blood samples in the first 4 days and extra-national patients (follow up not possible). Patients operated on both sides during the inclusion period were only included with data on their latest operation.
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 |
|---|---|---|
| Clopidogrel | Drug | Clopidogrel |
Primary outcome
Surgical Blood Loss
Time frame: at time of surgery
Blood loss as assessed by the surgeon
4 secondary outcomes
Total BLood Loss
Time frame: From admission to third day after surgery.
Number of transfusions
Time frame: From admission to third day after surgery
30 and 90 day mortality
Time frame: 30 and 90 days postoperatively
Massive transfusion
Time frame: within 24 hours of surgery
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 18 Mar 2015.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture, run by Hvidovre University Hospital.
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 1 inclusion and 1 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Surgical Blood Loss (time frame: at time of surgery). 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 18 Mar 2015.