Evaluation of Blood Loss During Knee Arthroplasty (SAD)

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.

Study Overview

• Status: Completed
• Conditions: Primary Knee Arthroplasty
• Intervention / Treatment: Procedure: Drainage

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 Type: Interventional
• Enrollment (Actual): 510
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75020
      • Groupe Hospitalier Diaconesses Croix Saint Simon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Drain; At the end of the knee arthroplasty, a drain is placed at the surgical site	Procedure: Drainage; At the end of the knee arthroplasty, a drain is placed or not at the surgical site depending on randomization result
Other: Without drain; At the end of the knee arthroplasty, a drain is not placed at the surgical site	Procedure: Drainage; At the end of the knee arthroplasty, a drain is placed or not at the surgical site depending on randomization result

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from the day before surgery until the 5th postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of blood transfusion during primary knee arthroplasty	Measurement of total blood transfused between surgery and the fifth day after surgery	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	From surgery up to the third month

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
• Investigators: Principal Investigator: Luc LHOTELLIER, MD, Groupe Hospitalier Diaconesses Croix Saint-Simon

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Drainage; Blood; Loss; Without drainage
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: ID RCB : 2019-A01710-57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No