Changes in Perioperative Blood Volume and Fluid Distribution in Patients Undergoing Primary Total Hip Replacement.

NCT06888908 | Recruiting

• 1 other identifier: H-24062107
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical assessment of bleeding and calculation of perioperative blood loss do not provide an accurate estimate of blood volume. This makes rational fluid management difficult, which is of high importance for patient-related outcomes. The availability of carbon monoxide(CO)-rebreathing allows for simple, non-invasive and precise measurement of changes in blood volume. The purpose of the study is to investigate and describe changes in blood volume and fluid distribution perioperative in patients undergoing total hip arthroplasty. Furthermore, to investigate the association between changes in blood volume and incidence of orthostatic insufficiency.

Conditions

Hip Arthroplasty Replacement

Keywords

Blood loss; Blood volume

Outcome Measures

Primary Outcomes (1)

• Change in total blood volume (TBV)

  Measured in milliliter (mL)

  Preoperatively and 6 hours postoperatively

Secondary Outcomes (13)

• Change in total blood volume (TBV)

  Preoperatively and 24 hours postoperatively

• Changes in total hemoglobin mass (tHgb)

  Preoperatively, 6 hours postoperatively and 24 hours postoperatively

• Changes in erythrocyte volume (EBV)

  Preoperatively, 6 hours postoperatively and 24 hours postoperatively

• Changes in plasma volume (PV)

  Preoperatively, 6 hours postoperatively and 24 hours postoperatively

• Changes in hematokrit (Ht)

  Preoperatively, 6 hours postoperatively and 24 hours postoperatively

Other Outcomes (2)

• Intraoperativ estimation of bleeding

  Intraoperative at end of the surgical procedure

• Intraoperative bleeding

  Intraoperative at end of the surgical procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for an elective total hip arthoplasty (THA) at Hvidovre University Hospital and undergo the proceduce under spinal anesthesia with propofol sedation.

You may qualify if:

• Patients scheduled for an elective total hip arthoplasty (THA) in a standardized fast track setting.
• Capable of participating in CO-rebreathing measurement
• Age ≥ 18 years
• Able to speak and understand Danish
• Has provided written informed consent.

You may not qualify if:

• Intraoperative blood loss exceeding 750 mL.
• Perioperative need for a blood transfusion.
• Confirmed or suspected coagulopathies.
• Factors that make CO-rebreathing measurement impossible.
• Known orthostatic intolerance.
• American Society of Anesthesiologists physical status (ASA) classification ≥ 4.

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead

Study Sites (1)

Hvidovre University Hospital

Copenhagen, 2960, Denmark

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolai Foss, Professor, Dr. Med.

  Department of Anesthesiology and Intensive Care Medicine, Copenhagen University Hospital, Hvidovre

  STUDY DIRECTOR

Central Study Contacts

Puk Kristiansen, MD

CONTACT

+4530291189; puk.kristiansen@regionh.dk

Ana-Marija Hristovska, Senior registrar, Ph.D.

CONTACT

ana-marija.hristovska.02@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.d.-student

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 21, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)