An observational study in Hip Fracture, sponsored by Hvidovre University Hospital. Completed. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Hvidovre University Hospital · Observational
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.
822 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.
This study's enrollment of 356 is above the median of 140 across 268 observational studies indexed under Hip Fractures.
Browse Hip Fractures studies →Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Patients in Clopidogrel or Dual Antiplatelet Therapy (Clopidogrel+Acetylsalicylic acid) at the time of admission AND who are operated \<24 hours after admission.
Drug: Clopidogrel
Patients NOT in anticoagulation treatment (Except acetylsalicylic acid) AND who are operated \<24 hours after admission.
Surgical Blood Loss
Blood loss as assessed by the surgeon
Time frame: at time of surgery
Total BLood Loss
Calculated based on the method described by Foss et al 2006 (Hidden Blood Loss in hip fractures)
Time frame: From admission to third day after surgery.
Number of transfusions
Number of Red Blood Cell transfusions
Time frame: From admission to third day after surgery
30 and 90 day mortality
Recorded from national persons registry (CPR-registeret)
Time frame: 30 and 90 days postoperatively
Massive transfusion
\>10 Red Blood Cell transfusion within 24 hours of surgery.
Time frame: within 24 hours of surgery
No study locations are listed for this record.
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Hvidovre University Hospital