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Completed

NCT Number: NCT02391883

Hip-Fracture Surgery on Patients in Clopidogrel Therapy

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clopidogrel

Drug

Primary outcomes

  1. Surgical Blood Loss

    Time frame: at time of surgery

    Blood loss as assessed by the surgeon

Secondary outcomes

  1. Total BLood Loss

    Time frame: From admission to third day after surgery.

    Calculated based on the method described by Foss et al 2006 (Hidden Blood Loss in hip fractures)

  2. Number of transfusions

    Time frame: From admission to third day after surgery

    Number of Red Blood Cell transfusions

  3. 30 and 90 day mortality

    Time frame: 30 and 90 days postoperatively

    Recorded from national persons registry (CPR-registeret)

  4. Massive transfusion

    Time frame: within 24 hours of surgery

    >10 Red Blood Cell transfusion within 24 hours of surgery.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Mar 18, 2015
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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