NCT04247178

Brief Summary

Approximately 20% of patients undergoing elective orthopaedic surgery are anaemic. When not identified and treated before surgery, this can lead to requiring blood transfusions, which brings additional expenses, time and inconvenience to the patient.It is recommended that preoperative assessment involves investigation and where possible, treatment of anaemia. The timescale between assessment and surgery makes it difficult to comply with guidelines without postponing surgery. This study will investigate adult patients scheduled for elective orthopaedic surgery, where a full blood count is to be taken as part of routine care. A paired non-invasive reading of their blood will be taken. It will be conducted at The Royal Infirmary, Edinburgh. This device is not in use within the department currently but has been given free of charge for the study. There are no restrictions placed on the device except that it is not accurate for measuring haemoglobin \<8g.dL. Participant care will only be determined by results from the laboratory assay as per routine care, not the noninvasive device. The device is CE marked for haemoglobin determination. Masimo (manufacturer) have released results in the accuracy of their monitor but with very little other information, for example, study population or precision. This study aims to answer how accurate and precise non-invasive measurements are in patients scheduled for orthopaedic surgery (there are no studies with these results) and whether anaemia can be identified earlier in the patient pathway i.e. an anaemia screen at time of surgical listing, therefore leaving ample time for treatment and optimisation of care. The data from the study will not be shared with Masimo. There is ongoing work towards introducing and piloting a new pre-operative triage system where optimisable conditions e.g. anaemia are identified at the time of listing. This study would aid this work.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 31, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

January 22, 2020

Last Update Submit

November 3, 2020

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • The accuracy of the non-invasive device

    assessed by calculating the agreement between the results obtained from the gold standard laboratory assay and the non-invasive device

    January to March 2020

Secondary Outcomes (13)

  • Correlation of the non-invasive device to the gold standard

    January to March 2020

  • Correlation of the non-invasive device to the gold standard

    January to March 2020

  • Predictive value of the non-invasive device

    January to March 2020

  • Predictive value of the non-invasive device

    January to March 2020

  • Predictive value of the non-invasive device

    January to March 2020

  • +8 more secondary outcomes

Study Arms (2)

Patients undergoing elective orthopaedic surgery

Healthy Volunteers

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for elective orthopaedic surgery. Healthy volunteers will be recruited from The Department of Anaesthetics.

You may qualify if:

  • able to provide informed consent
  • aged between 16-80 years old
  • scheduled for elective orthopaedic surgery
  • a full blood count (FBC) is to be taken as part of routine care
  • able to provide informed consent
  • aged between 16-80 years old

You may not qualify if:

  • Patients with haemoglobin disorders
  • Raynaud's disease (or any other condition affecting the blood supply to the digits).
  • Patients with haemoglobin disorders
  • Raynaud's disease (or any other condition affecting the blood supply to the digits).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, The City of Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 29, 2020

Study Start

January 31, 2020

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

GB(1)