Hip Arthroplasty ReplacementNCT06888908
Changes in Perioperative Blood Volume and Fluid Distribution in Patients Undergoing Primary Total Hip Replacement.
An observational study of Hip Arthroplasty Replacement, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthroplasty Replacement
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ana-Marija Hristovska, Senior registrar, Ph.D. contact
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre University Hospital
Copenhagen, 2960
About this study
Official title: Perioperative Change in Blood Volume and Fluid Distribution in Total Hip Arthroplasty
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
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total blood volume (TBV)
Measured in milliliter (mL)
Measured: Preoperatively and 6 hours postoperatively
Secondary outcomes (13)
Change in total blood volume (TBV)
measured in mL
Measured: Preoperatively and 24 hours postoperatively
Changes in total hemoglobin mass (tHgb)
Measured in gram (g)
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in erythrocyte volume (EBV)
Measured in mL
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in plasma volume (PV)
Measured in mL
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in hematokrit (Ht)
Reported as percentage(%)
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in hemoglobin (Hg) concentration
Measured in millimoles/liter(mmol/L)
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in Total body water(TBW), intra-(ICF) and extracellular(ECF) fluid distribution
Full body water via bioelectrical impedance analysis. The individual components are reported in L and percent.
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in C-Reactive Protein (CRP)
Measured in milligram/liter (mg/L)
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Incidence of orthostatic intolerance during mobilization
Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Association between total blood loss and incidence of orthostatic intolerance
Blood loss measured in mL. Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Association between changes in C-Reactive Protein and total blood loss
C-Reactive Protein measured in mg/L and total blood loss measured in mL
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Association between peripheral perfusion index and total blood loss
Peripheral perfusion index measured in percent and total blood loss in mL
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Association between total hemoglobin (SpHb) and total blood loss
SpHb measured as gram/deciliter and total blood loss measured in mL
Measured: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Arthroplasty ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Puk Kristiansen, Copenhagen University Hospital, Hvidovre
- Investigators
- Nicolai Foss, Professor, Dr. Med., Study director, Department of Anesthesiology and Intensive Care Medicine, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888908
- Sponsor's protocol ID
- H-24062107
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Change in Blood Volume and Fluid Distribution in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06888908
- Acronym / sponsor ID
- H-24062107
- Conditions
- Hip Arthroplasty Replacement
- Keywords
- Blood loss, Blood volume
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in total blood volume (TBV)
Time frame: Preoperatively and 6 hours postoperatively
Measured in milliliter (mL)
13 secondary outcomes
Change in total blood volume (TBV)
Time frame: Preoperatively and 24 hours postoperatively
Changes in total hemoglobin mass (tHgb)
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in erythrocyte volume (EBV)
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in plasma volume (PV)
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in hematokrit (Ht)
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in hemoglobin (Hg) concentration
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in Total body water(TBW), intra-(ICF) and extracellular(ECF) fluid distribution
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Changes in C-Reactive Protein (CRP)
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Incidence of orthostatic intolerance during mobilization
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Association between total blood loss and incidence of orthostatic intolerance
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Association between changes in C-Reactive Protein and total blood loss
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Association between peripheral perfusion index and total blood loss
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Association between total hemoglobin (SpHb) and total blood loss
Time frame: Preoperatively, 6 hours postoperatively and 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana-Marija Hristovska, Senior registrar, Ph.D. contact
Nicolai Foss, Professor, Dr. Med. study director
Department of Anesthesiology and Intensive Care Medicine, Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthroplasty Replacement, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Puk Kristiansen, MD (+4530291189, puk.kristiansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total blood volume (TBV) (time frame: Preoperatively and 6 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.