An Algorithm for Predicting Blood Loss and Transfusion Risk in Fast Track Total Hip Arthroplasty

April 21, 2016 updated by: Riccardo Compagnoni, Azienda Ospedaliera Bolognini di Seriate Bergamo
Aim of these study is to create an algorithm, using data from patients that undergoing total hip arthroplasty, to predict blood loss after surgery and permit a safe domestic discharge.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Two different cohorts of patients undergoing total hip arthroplasty will be analyzed to obtain data about hemoglobin trends. The first group will be used to obtain the algorithm, the second one to validate results of the first group, determining sensitivity and specificity.

Study Type

Observational

Enrollment (Actual)

124

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

124 patients, in two different cohorts, undergoing total hip arthroplasty.

Description

Inclusion Criteria:

  • Patients with hip arthritis

Exclusion Criteria:

  • ASA 4 - 5
  • Active treatment with warfarin
  • Coagulation disorders

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Analysis group
Create an algorithm to predict blood loss using patients data
Procedure: Total hip arthroplasty, blood loss analysis
Data analysis about blood loss in total hip replacement
Control group
The algorithm was applied to analyze sensitivity and specificity
Procedure: Total hip arthroplasty, blood loss analysis
Data analysis about blood loss in total hip replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Create an algorithm to predict blood loss after total hip arthroplasty
Time Frame: 3 months
Data from the fist cohort of patients have been collected and analyzed to obtain an algorithm describing the trends of hemoglobin values after total hip arthroplasty. These algorithm was after applied to patients of a second cohort of consecutive patients undergoing total hip arthroplasty to determine specificity and sensitivity.
3 months

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera Bolognini di Seriate Bergamo

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

April 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Blood algorithm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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