Hip-Fracture Surgery on Patients in Clopidogrel Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02391883

Enrollment

356

Registered

2015-03-18

Start date

2011-01-31

Completion date

2015-02-28

Last updated

2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture

Keywords

clopidogrel therapy, platelet aggregation inhibitor, adverse event

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.

Interventions

DRUGClopidogrel

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Surgical Blood Loss	at time of surgery	Blood loss as assessed by the surgeon

Secondary

Measure	Time frame	Description
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)
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)
Massive transfusion	within 24 hours of surgery	\>10 Red Blood Cell transfusion within 24 hours of surgery.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026