Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02750852
Recruitment Status : Unknown
Verified April 2016 by Riccardo Compagnoni, Azienda Ospedaliera Bolognini di Seriate Bergamo.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Riccardo Compagnoni, Azienda Ospedaliera Bolognini di Seriate Bergamo

Brief Summary:
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.

Condition or disease Intervention/treatment
Total Hip Replacement Blood Loss Procedure: Total hip arthroplasty, blood loss analysis

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An Algorithm for Predicting Blood Loss and Transfusion Risk in Fast Track Total Hip Arthroplasty
Study Start Date : April 2016
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
124 patients, in two different cohorts, undergoing total hip arthroplasty.
Criteria

Inclusion Criteria:

  • Patients with hip arthritis

Exclusion Criteria:

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

Layout table for additonal information
Responsible Party: Riccardo Compagnoni, Medical doctor, Azienda Ospedaliera Bolognini di Seriate Bergamo
ClinicalTrials.gov Identifier: NCT02750852     History of Changes
Other Study ID Numbers: Blood algorithm
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Pathologic Processes