Hip-Fracture Surgery on Patients in Clopidogrel Therapy

Hip Fracture Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391883
• Other study ID #: CLOP-HIPFX study
• Status: Completed
• Phase: N/A
• First received: March 12, 2015
• Last updated: March 17, 2015
• Start date: January 2011
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: February 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Clopidogrel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Blood Loss	Blood loss as assessed by the surgeon	at time of surgery	No
Secondary	Total BLood Loss	Calculated based on the method described by Foss et al 2006 (Hidden Blood Loss in hip fractures)	From admission to third day after surgery.	No
Secondary	Number of transfusions	Number of Red Blood Cell transfusions	From admission to third day after surgery	No
Secondary	30 and 90 day mortality	Recorded from national persons registry (CPR-registeret)	30 and 90 days postoperatively	No
Secondary	Massive transfusion	>10 Red Blood Cell transfusion within 24 hours of surgery.	within 24 hours of surgery	No