Hip-Fracture Surgery on Patients in Clopidogrel Therapy

NCT02391883 | Completed DMC

• 1 other identifier: CLOP-HIPFX study
• Study Type: observational
• Target: 356
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Fracture

Keywords

clopidogrel therapy; platelet aggregation inhibitor; adverse event

Outcome Measures

Primary Outcomes (1)

• Surgical Blood Loss

  Blood loss as assessed by the surgeon

  at time of surgery

Secondary Outcomes (4)

• Total BLood Loss

  From admission to third day after surgery.

• Number of transfusions

  From admission to third day after surgery

• 30 and 90 day mortality

  30 and 90 days postoperatively

• Massive transfusion

  within 24 hours of surgery

Study Arms (2)

Clopidogrel

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

Control

Patients NOT in anticoagulation treatment (Except acetylsalicylic acid) AND who are operated \<24 hours after admission.

Interventions

Clopidogrel DRUG

Clopidogrel

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

MeSH Terms

Conditions

Hip Fractures

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2015
• Last Updated: March 18, 2015

Record last verified: 2015-03