Primary Knee ArthroplastySADNCT06052982
Evaluation of Blood Loss During Knee Arthroplasty
A study testing Drainage in people with Primary Knee Arthroplasty, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
Primary arthroplasties are frequent interventions that can present hemorrhagic complications: postoperative hematoma, deglobulization justifying monitoring blood tests and blood transfusion if necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Knee Arthroplasty
- What is being tested?
- Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2022to 10 Jul 2023
- 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
- Patient consent
- Patient aged over 18 years
- Patient scheduled for primary knee arthroplasty
Who cannot join
- Patient expresses his/her opposition to participating in the study
- Patient scheduled for revision, revision or totalization arthroplasty
- Primary arthroplasty after septic arthritis
- Patient requiring an additional planned or unplanned surgical procedure such as TTTA, osteosynthesis for an intraoperative fracture and/or removal of material
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, Île-de-France Region, 75020
About this study
Official title: Comparative Randomized Study Evaluating Intra and Postoperative Total Blood Loss During Primary Knee Arthroplasty, With Drainage Versus Non-drainage
Primary arthroplasties are frequent interventions that can present hemorrhagic complications: postoperative hematoma, deglobulization justifying monitoring blood tests and blood transfusion if necessary.
The attitude regarding the drainage of the surgical site supposed to limit these events differs from one surgeon to another, even in the same team. Its use is common practice; for some, systematic. For others, depending on intraoperative findings or the patient's condition. For others, the drain is never laid.
Faced with the divergence of data from the literature on the benefit of the placement of a drain for intra and postoperative bleeding in knee arthroplasty, the lack of randomized prospective studies on large series of patients, and in a desire to homogenization and standardization of the operating procedure of our surgeons, investigators decided to conduct this prospective interventional, comparative and randomized study.
Read the detailed description
After obtaining the patient's consent and randomisation, the operating surgeon will have the information of placing or not a drain, lately at the end of the intervention so that the course of the intervention is not influenced by the prior knowledge of the patient randomization arm.
Investigators will carry out especially within the framework of this research 3 samples of a total of 10.7 ml of whole blood (appendix. 12.5) distributed as follows:
Sample no. 1 : 2.7 ml of blood in a hemostasis tube (sodium citrate tube) one day before the procedure (D-1) for the determination of the prothrombin level (PT), activated partial thromboplastin time ( TCA) and the INR or International Normalized Ratio.
Sample no. 2 : 4 ml of blood in a purple EDTA tube for NFS, one day before the operation (D-1) for the determination of hemoglobin ( Hb ) and hematocrit ( Hct ) Sample no. 3 : 4 ml of blood in a violet EDTA tube for NFS for the determination of hemoglobin ( Hb ) and hematocrit ( Hct ) on the fifth postoperative day (D5). This last assessment will be prescribed to the patient to be carried out in the rehabilitation center..
The knee prosthesis implantation surgical technique is performed according to the standard operating procedure of the orthopedic surgery team.
According to the operating standard procedure of our orthopedic department, the drain is non-aspirated for 6 hours and then put back under vacuum until the morning after the knee prosthesis operation.
Three months after the intervention the patient will be seen again in consultation and examined.
- Conditions
- Primary Knee Arthroplasty
- Being tested
- Drainage
- Keywords
- Blood, Loss, Drainage, Without drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrainageProcedure or surgery
At the end of the knee arthroplasty, a drain is placed or not at the surgical site depending on randomization result
| Study group | Role | What they receive |
|---|---|---|
| Drain | Other | At the end of the knee arthroplasty, a drain is placed at the surgical site Receives: Procedure: Drainage |
| Without drain | Other | At the end of the knee arthroplasty, a drain is not placed at the surgical site Receives: Procedure: Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin dosage and bleeding quantification in both groups
Estimation of blood loss with Mercuriali Formula. This formula requires the patient's blood volume and requires the volume of red blood cells transfused as well.
Measured: from the day before surgery until the 5th postoperative day
Secondary outcomes (2)
Assessment of blood transfusion during primary knee arthroplasty
Measurement of total blood transfused between surgery and the fifth day after surgery
Measured: from surgery until the 5th postoperative day
Number of patients with complications after knee arthroplasty in the two groups
Monitoring for complications from surgery up to 3 months
Measured: From surgery up to the third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start10 Apr 2022
- Primary completion10 Apr 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Knee ArthroplastyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr LHOTELLIER Luc, Groupe Hospitalier Diaconesses Croix Saint-Simon
- Investigators
- Luc LHOTELLIER, MD, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052982
- Sponsor's protocol ID
- ID RCB : 2019-A01710-57
- Acronym
- SAD
- Status last verified
- Sep 2023
- First submitted
- 23 Mar 2023
- Last updated
- 25 Sep 2023
- 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 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized Study Evaluating Intra and Postoperative Total Blood Loss During Primary Knee Arthroplasty, With Drainage Versus Non-drainage
- ClinicalTrials.gov ID
- NCT06052982
- Acronym / sponsor ID
- SAD / ID RCB : 2019-A01710-57
- Conditions
- Primary Knee Arthroplasty
- Keywords
- Blood, Loss, Drainage, Without drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 25 Sep 2023 (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.
Primary arthroplasties are frequent interventions that can present hemorrhagic complications: postoperative hematoma, deglobulization justifying monitoring blood tests and blood transfusion if necessary.
The attitude regarding the drainage of the surgical site supposed to limit these events differs from one surgeon to another, even in the same team. Its use is common practice; for some, systematic. For others, depending on intraoperative findings or the patient's condition. For others, the drain is never laid.
Faced with the divergence of data from the literature on the benefit of the placement of a drain for intra and postoperative bleeding in knee arthroplasty, the lack of randomized prospective studies on large series of patients, and in a desire to homogenization and standardization of the operating procedure of our surgeons, investigators decided to conduct this prospective interventional, comparative and randomized study.
Detailed description
After obtaining the patient's consent and randomisation, the operating surgeon will have the information of placing or not a drain, lately at the end of the intervention so that the course of the intervention is not influenced by the prior knowledge of the patient randomization arm.
Investigators will carry out especially within the framework of this research 3 samples of a total of 10.7 ml of whole blood (appendix. 12.5) distributed as follows:
Sample no. 1 : 2.7 ml of blood in a hemostasis tube (sodium citrate tube) one day before the procedure (D-1) for the determination of the prothrombin level (PT), activated partial thromboplastin time ( TCA) and the INR or International Normalized Ratio.
Sample no. 2 : 4 ml of blood in a purple EDTA tube for NFS, one day before the operation (D-1) for the determination of hemoglobin ( Hb ) and hematocrit ( Hct ) Sample no. 3 : 4 ml of blood in a violet EDTA tube for NFS for the determination of hemoglobin ( Hb ) and hematocrit ( Hct ) on the fifth postoperative day (D5). This last assessment will be prescribed to the patient to be carried out in the rehabilitation center..
The knee prosthesis implantation surgical technique is performed according to the standard operating procedure of the orthopedic surgery team.
According to the operating standard procedure of our orthopedic department, the drain is non-aspirated for 6 hours and then put back under vacuum until the morning after the knee prosthesis operation.
Three months after the intervention the patient will be seen again in consultation and examined.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drain | Other | Procedure: DrainageAt the end of the knee arthroplasty, a drain is placed at the surgical site |
| Without drain | Other | Procedure: DrainageAt the end of the knee arthroplasty, a drain is not placed at the surgical site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient consent
- Patient aged over 18 years
- Patient scheduled for primary knee arthroplasty
Key exclusion criteria (4 listed)
- Patient expresses his/her opposition to participating in the study
- Patient scheduled for revision, revision or totalization arthroplasty
- Primary arthroplasty after septic arthritis
- Patient requiring an additional planned or unplanned surgical procedure such as TTTA, osteosynthesis for an intraoperative fracture and/or removal of material
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 |
|---|---|---|
| DrainageAt the end of the knee arthroplasty, a drain is placed or not at the surgical site depending on randomization result | Procedure or surgery | Drain, Without drain |
Primary outcome
Hemoglobin dosage and bleeding quantification in both groups
Time frame: from the day before surgery until the 5th postoperative day
Estimation of blood loss with Mercuriali Formula. This formula requires the patient's blood volume and requires the volume of red blood cells transfused as well.
2 secondary outcomes
Assessment of blood transfusion during primary knee arthroplasty
Time frame: from surgery until the 5th postoperative day
Number of patients with complications after knee arthroplasty in the two groups
Time frame: From surgery up to the third month
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 25 Sep 2023.
- 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. This study is not recruiting at the moment.
Luc LHOTELLIER, MD principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drainage in people with Primary Knee Arthroplasty, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
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 4 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 25 Sep 2023. 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 France. 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?
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?
Hemoglobin dosage and bleeding quantification in both groups (time frame: from the day before surgery until the 5th postoperative day). 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 25 Sep 2023.