Clinical trial NCT06052982: Evaluation of Blood Loss During Knee Arthroplasty
Official title: Comparative Randomized Study Evaluating Intra and Postoperative Total Blood Loss During Primary Knee Arthroplasty, With Drainage Versus Non-drainage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Knee Arthroplasty
Keywords: Blood
Loss
Drainage
Without drainage
Lead sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Patient consent
* Patient aged over 18 years
* Patient scheduled for primary knee arthroplasty

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hemoglobin dosage and bleeding quantification in both groups
timeFrame: from the day before surgery until the 5th postoperative day
Secondary outcomes:
measure: Assessment of blood transfusion during primary knee arthroplasty
timeFrame: from surgery until the 5th postoperative day
measure: Number of patients with complications after knee arthroplasty in the two groups
timeFrame: From surgery up to the third month
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint Simon
state: Ile De France
Study officials:
affiliation: Groupe Hospitalier Diaconesses Croix Saint-Simon
name: Luc LHOTELLIER, MD
role: PRINCIPAL_INVESTIGATOR
References: