NCT02750852

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

Same day

First QC Date

April 21, 2016

Last Update Submit

April 21, 2016

Conditions

Total Hip ReplacementBlood Loss

Outcome Measures

Primary Outcomes (1)

  • Create an algorithm to predict blood loss after total hip arthroplasty

    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

Study Arms (2)

Analysis group

Create an algorithm to predict blood loss using patients data

Procedure: Total hip arthroplasty, blood loss analysis

Control group

The algorithm was applied to analyze sensitivity and specificity

Procedure: Total hip arthroplasty, blood loss analysis

Interventions

Total hip arthroplasty, blood loss analysisPROCEDURE

Data analysis about blood loss in total hip replacement

Analysis groupControl group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients with hip arthritis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemorrhage

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 26, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

April 26, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share