TransfusionNCT04304287
The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty
A study testing Preoperative autologous blood donation, 14 days before surgery, Preoperative autologous blood donation, 72 hours before surgery and Without preoperative blood donation in people with Transfusion and Hip Arthroplasty, run by Clinical Hospital Centre Zagreb.
Trial summary
The investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfusion, Hip Arthroplasty
- What is being tested?
- Preoperative autologous blood donation, 14 days before surgery, Preoperative autologous blood donation, 72 hours before surgery and Without preoperative blood donation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 16 Jan 2011to 15 Jun 2015
- Phase
- Interventional
- 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
Who may be able to join
- subject older than 18 years
- subject has primary coxarthrosis
- subject has indication for total hip replacement
Who cannot join
- subject has secondary coxarthrosis
- subject has need for revision endoprosthesis
- history of autoimmune, malignancy or coagulation disorder
- history of myocardial infarct or cerebrovascular insult in last 6 months
- history of angina pectoris and unregulated hypertension
- history of renal or liver failure
About this study
The investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.
Read the detailed description
Total hip arthroplasty is procedure followed with large perioperative and postoperative blood loss. In order to avoid the application of large amounts of allogeneic blood, preoperative autologous blood donation as a tipe of autologous transfusion have been developed.
In this study, the investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.
Participants were divided into three groups: the first group donated one dose of autologous blood 14 days preoperatively, the second group donated one dose of autologous blood 72 hours preoperatively and a third group was not donated autologous blood.
The blood parameters, hemodynamic stability, bleeding, the need for application of autologous or homologous blood and length of hospital stay were compared.
- Conditions
- Transfusion, Hip Arthroplasty
- Being tested
- Preoperative autologous blood donation, 14 days before surgery, Preoperative autologous blood donation, 72 hours before surgery, Without preoperative blood donation
- Keywords
- total hip arthroplasty, autologous blood donation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative autologous blood donation, 14 days before surgeryProcedure or surgery
Preoperative autologous blood donation, 72 hours before surgeryProcedure or surgery
Without preoperative blood donationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Preoperative blood donations 14 day before total hip replacement procedure Donation of one dose of autologous blood 14 day before total hip replacement procedure Receives: Procedure: Preoperative autologous blood donation, 14 days before surgery |
| Active comparator | Active comparator | Preoperative blood donation 72 hours before total hip replacement procedure Donation of one dose of autologous blood 72 hours before total hip replacement procedure Receives: Procedure: Preoperative autologous blood donation, 72 hours before surgery |
| Other | Other | Without preoperative blood donation Receives: Procedure: Without preoperative blood donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient red blood cells value
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
Measured: 6 days
Need for autologous blood transfusion
Based on blood count and hemodynamic stability
Measured: 6 days
Need for homologous blood transfusion
Based on blood count and hemodynamic stability
Measured: 6 days
Patient hemoglobin value
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
Measured: 6 days
Patient hematocrit value
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
Measured: 6 days
Secondary outcomes (1)
Length of hospital stay
measure of length of hospital stay
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start16 Jan 2011
- Primary completion15 Jun 2013
- Study completion15 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransfusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zrinka Oreskovic, Clinical Hospital Centre Zagreb
- Investigators
- Domagoj Delimar, MD, Study director, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304287
- Sponsor's protocol ID
- Orthopedia/autotransfusion
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2020
- Last updated
- 23 Mar 2020
- 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 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04304287
- Acronym / sponsor ID
- Orthopedia/autotransfusion
- Conditions
- Transfusion, Hip Arthroplasty
- Keywords
- total hip arthroplasty, autologous blood donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- 16 Jan 2011 (actual)
- Primary completion
- 15 Jun 2013 (actual)
- Study completion
- 15 Jun 2015 (actual)
- First posted
- 11 Mar 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.
The investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.
Detailed description
Total hip arthroplasty is procedure followed with large perioperative and postoperative blood loss. In order to avoid the application of large amounts of allogeneic blood, preoperative autologous blood donation as a tipe of autologous transfusion have been developed.
In this study, the investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.
Participants were divided into three groups: the first group donated one dose of autologous blood 14 days preoperatively, the second group donated one dose of autologous blood 72 hours preoperatively and a third group was not donated autologous blood.
The blood parameters, hemodynamic stability, bleeding, the need for application of autologous or homologous blood and length of hospital stay were compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Preoperative autologous blood donation, 14 days before surgeryPreoperative blood donations 14 day before total hip replacement procedure Donation of one dose of autologous blood 14 day before total hip replacement procedure |
| Active comparator | Active comparator | Procedure: Preoperative autologous blood donation, 72 hours before surgeryPreoperative blood donation 72 hours before total hip replacement procedure Donation of one dose of autologous blood 72 hours before total hip replacement procedure |
| Other | Other | Procedure: Without preoperative blood donationWithout preoperative blood donation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subject older than 18 years
- subject has primary coxarthrosis
- subject has indication for total hip replacement
Key exclusion criteria (6 listed)
- subject has secondary coxarthrosis
- subject has need for revision endoprosthesis
- history of autoimmune, malignancy or coagulation disorder
- history of myocardial infarct or cerebrovascular insult in last 6 months
- history of angina pectoris and unregulated hypertension
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 |
|---|---|---|
| Preoperative autologous blood donation, 14 days before surgery | Procedure or surgery | Experimental |
| Preoperative autologous blood donation, 72 hours before surgery | Procedure or surgery | Active comparator |
| Without preoperative blood donation | Procedure or surgery | Other |
Primary outcome
Patient red blood cells value
Time frame: 6 days
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
Need for autologous blood transfusion
Time frame: 6 days
Based on blood count and hemodynamic stability
Need for homologous blood transfusion
Time frame: 6 days
Based on blood count and hemodynamic stability
Patient hemoglobin value
Time frame: 6 days
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
Patient hematocrit value
Time frame: 6 days
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
1 secondary outcome
Length of hospital stay
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Transfusion
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 3
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
Myelodysplastic Syndromes
RecruitingPhase 3
A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions
Myelodysplastic Syndrome, Anemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingPhase 1/2
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Dibotatug (DR-01) in Adults With Bone Marrow Failure Syndromes
Bone Marrow Failure Syndromes, Aplastic Anemias
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.
Domagoj Delimar, MD study director
Clinical Hospital Centre Zagreb
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative autologous blood donation, 14 days before surgery, Preoperative autologous blood donation, 72 hours before surgery and Without preoperative blood donation in people with Transfusion and Hip Arthroplasty, run by Clinical Hospital Centre Zagreb.
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 3 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: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient red blood cells value (time frame: 6 days). The study lists 5 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 23 Mar 2020.