Fast Reversal of Warfarin and Early Surgery in Patients With Trochanteric Hip Fracture A Case-control Study

October 28, 2020 updated by: Leif Mattisson, Karolinska Institutet

Is Fast Reversal and Early Surgery (Within 24 h) in Patients on Warfarin Medication With Trochanteric Hip Fractures Safe: A Case-control Study

A retrospective case-control study. To evaluate if early surgery within 24hours of troch or subtrochanteric hip fractures using intramedullary nailing is safe in patients on warfarin treatment after fast reversal of the warfarin effect

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Sjukhusbacken 10
      • Stockholm, Sjukhusbacken 10, Sweden, 11883
        • Södersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients on warfarin, with low-energi trauma, >60years, mean 86 years Op at Stockholm South General Hospital (södersjukhuset) between (Jan 1,2011 - Dec 31,2014) Follow-up 1 year, all pat op within 24 hours from hospital arrival to the surgery. Operated with Intramedullary nail due to unstable intertrochanteric (OTA/AO 31A2, A3) or Subtrochanteric fracture (OTA/AO 32A,32B,32C).

Description

Exclusion Criteria:

  • Pathological fracture
  • Late presentation to the hospital
  • Other injuries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
99 warfarin patients
warfarin patients were operated within 24 h with a cephalomedullary nail due to a trochanteric or subtrochanteric hip fracture. All patients on warfarin were reversed if necessary to INR≤1.5 before surgery using vitamin K and/or four-factor prothrombin complex concentrate (PCC)
99 patients without anticoagulants
As a 1:1 ratio control group matched for age, gender and surgical implant. All patients were operated within 24 h with a cephalomedullary nail due to a trochanteric or subtrochanteric hip fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfusion rates
Time Frame: Pre-surgery
Hb value (g/dl)
Pre-surgery
Transfusion rates
Time Frame: Pre-surgery
Transfusion rate (n)
Pre-surgery
Transfusion rates
Time Frame: During the surgery
Hb value (g/dl)
During the surgery
Transfusion rates
Time Frame: During the surgery
Transfusion rate (n)
During the surgery
Transfusion rates
Time Frame: 2-4 days after the surgery
Hb value (g/dl)
2-4 days after the surgery
Transfusion rates
Time Frame: 2-4 days after the surgery
Transfusion rate (n)
2-4 days after the surgery
adverse events
Time Frame: Immediately after the surgery
Number of patients with a myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, sepsis, pneumonia, urinary tract infection, pressure ulcer, or any adverse events.
Immediately after the surgery
mortality
Time Frame: Immediately after the surgery
The number of deaths
Immediately after the surgery
mortality
Time Frame: 30-days after the surgery
The number of deaths
30-days after the surgery
mortality
Time Frame: 1 year after the surgery
The number of deaths
1 year after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Stockholm South General Hospital

Investigators

  • Principal Investigator: Leif Mattisson, Stockholm South General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

June 26, 2018

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (ACTUAL)

November 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leif Mattisson

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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