Total Hip ReplacementI-SIGHT-THRNCT04442373
Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm
An observational study of Total Hip Replacement and Thromboelastometry, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Total hip replacement (THR) is associated with extensive tissue injury and considerable blood loss that can be complicated by hyperfibrinolysis with an increased need for blood transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve or maintain the function and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement, Thromboelastometry, Bone Neoplasm of Hip
- What is being tested?
- Rotational thromboelastometry
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 undergoing elective total hip replacement
Who may be able to join
- Adult patients undergoing primary elective total hip replacement
Who cannot join
- Patients unable to consent to trial
- Active deep and superficial vein thrombosis
- Coagulopathy in initial coagulation screen tests
- Platelet count below 100 thousand
- Patients on antithrombotic medications (except prophylactic low molecular weight heparins and acetylsalicylic acid up to 75 mg per day)
- Preoperative haemoglobin < 10 g/dl
- Female patients who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
I Department of Anesthesiology and Intensive Care Warsaw Medical University
Warsaw, Masovian Voivodeship, 02-005
Marek Janiak, MD, 0048225021724, klinanest1@wum.edu.pl
About this study
Official title: Impact of Surgical Injury on Global Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Bone Neoplasm. A Single-centre Observational Prospective Trial
Total hip replacement (THR) is associated with extensive tissue injury and considerable blood loss that can be complicated by hyperfibrinolysis with an increased need for blood transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve or maintain the function and quality of life. However, these patients have an increased likelihood of haemostatic abnormalities, such as thrombosis or extensive blood loss. Rotational thromboelastometry is a point-of-care viscoelastic assay that can provide a measure of coagulation disorders in the above settings, and this is still under review. The objective of this prospective cohort study is to quantitate the changes in clot formation dynamics following THR with a subgroup analysis of patients with cancer.
- Being tested
- Rotational thromboelastometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational thromboelastometryDiagnostic test
Also called ROTEM
1.8 ml blood sample
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing THR with no known bone neoplasm | Pre- and postoperative blood sampling for ROTEM assessment in THR patients Receives: Diagnostic Test: Rotational thromboelastometry | |
| Patients undergoing THR with known bone neoplasm | Pre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm Receives: Diagnostic Test: Rotational thromboelastometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
INTEM parameters change from preoperative to postoperative values
Measured: 30 minutes before and 30 minutes after surgery
EXTEM parameters change from preoperative to postoperative values
Measured: 30 minutes before and 30 minutes after surgery
FIBTEM parameter change from preoperative to postoperative values
Measured: 30 minutes before and 30 minutes after surgery
Secondary outcomes (6)
Total volume of infused fluids
Crystalloids, blood products
Measured: From first fluid on day of surgery to end of surgery, an average of 12 hours
Pre- and postoperative haemoglobin and haematocrit
Measured: From day before surgery to postoperative day 3
Intraoperative blood loss
Amount of blood loss in millilitres
Measured: Blood loss as measured during surgery
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Instrument for measuring outcome following surgery with higher scores representing better function. Score from 0 to 100.
Measured: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
The 36-Item Short Form Health Survey (SF-36)
Health related Quality of Life measure. Higher score indicates better health state with eight scaled scores each from 0 to 100.
Measured: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
Visual Analogue Scale (VAS) score
The ends of the scale are defined as the extreme limits of the pain. Orientated from the left (no pain) to the right (worst imaginable pain) measured in millimeters from 0 to 100.
Measured: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Pluta, Medical University of Warsaw
- Investigators
- Jan Pluta, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442373
- Sponsor's protocol ID
- ROTEM-THR
- Acronym
- I-SIGHT-THR
- Status last verified
- Jan 2024
- First submitted
- 8 Mar 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Surgical Injury on Global Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Bone Neoplasm. A Single-centre Observational Prospective Trial
- ClinicalTrials.gov ID
- NCT04442373
- Acronym / sponsor ID
- I-SIGHT-THR / ROTEM-THR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Jun 2020 (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.
Total hip replacement (THR) is associated with extensive tissue injury and considerable blood loss that can be complicated by hyperfibrinolysis with an increased need for blood transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve or maintain the function and quality of life. However, these patients have an increased likelihood of haemostatic abnormalities, such as thrombosis or extensive blood loss. Rotational thromboelastometry is a point-of-care viscoelastic assay that can provide a measure of coagulation disorders in the above settings, and this is still under review. The objective of this prospective cohort study is to quantitate the changes in clot formation dynamics following THR with a subgroup analysis of patients with cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing THR with no known bone neoplasm | – | Diagnostic Test: Rotational thromboelastometryPre- and postoperative blood sampling for ROTEM assessment in THR patients |
| Patients undergoing THR with known bone neoplasm | – | Diagnostic Test: Rotational thromboelastometryPre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective total hip replacement
Key inclusion criteria (1 listed)
- Adult patients undergoing primary elective total hip replacement
Key exclusion criteria (7 listed)
- Patients unable to consent to trial
- Active deep and superficial vein thrombosis
- Coagulopathy in initial coagulation screen tests
- Platelet count below 100 thousand
- Patients on antithrombotic medications (except prophylactic low molecular weight heparins and acetylsalicylic acid up to 75 mg per day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotational thromboelastometryAlso: ROTEM1.8 ml blood sample | Diagnostic test | Patients undergoing THR with known bone neoplasm, Patients undergoing THR with no known bone neoplasm |
Primary outcome
INTEM parameters change from preoperative to postoperative values
Time frame: 30 minutes before and 30 minutes after surgery
EXTEM parameters change from preoperative to postoperative values
Time frame: 30 minutes before and 30 minutes after surgery
FIBTEM parameter change from preoperative to postoperative values
Time frame: 30 minutes before and 30 minutes after surgery
6 secondary outcomes
Total volume of infused fluids
Time frame: From first fluid on day of surgery to end of surgery, an average of 12 hours
Pre- and postoperative haemoglobin and haematocrit
Time frame: From day before surgery to postoperative day 3
Intraoperative blood loss
Time frame: Blood loss as measured during surgery
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time frame: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
The 36-Item Short Form Health Survey (SF-36)
Time frame: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
Visual Analogue Scale (VAS) score
Time frame: The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Jan Pluta, MD principal investigator
Medical University of Warsaw
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 Total Hip Replacement and Thromboelastometry, run by Medical University of Warsaw at 1 site in Poland.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Janiak, MD (0048225021724, mjaniak1@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INTEM parameters change from preoperative to postoperative values (time frame: 30 minutes before and 30 minutes after surgery). The study lists 3 primary outcomes in all. 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 17 Jan 2024.