Hip-Fracture Surgery on Patients in Clopidogrel Therapy

Completed

• Conditions: Hip Fracture
• Interventions: Drug: Clopidogrel

• Registration Number: NCT02391883
• Lead Sponsor: Hvidovre University Hospital

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-12
• Study Completion: 2015-02
• Status Verified: 2015-03
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-17
• Last Update Submitted: 2015-03-17
• Study First Posted: 2015-03-18
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

• All patients operated with short intramedullary nail for hip-fractures, in the study period. (1st of Jan. 2011-31st of Dec. 2013)

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clopidogrel	Clopidogrel	Patients in Clopidogrel or Dual Antiplatelet Therapy (Clopidogrel+Acetylsalicylic acid) at the time of admission AND who are operated \<24 hours after admission.

Primary Outcome Measures

Name	Time	Method
Surgical Blood Loss	at time of surgery	Blood loss as assessed by the surgeon

Secondary Outcome Measures

Name	Time	Method
Massive transfusion	within 24 hours of surgery	\>10 Red Blood Cell transfusion within 24 hours of surgery.
Number of transfusions	From admission to third day after surgery	Number of Red Blood Cell transfusions
30 and 90 day mortality	30 and 90 days postoperatively	Recorded from national persons registry (CPR-registeret)
Total BLood Loss	From admission to third day after surgery.	Calculated based on the method described by Foss et al 2006 (Hidden Blood Loss in hip fractures)