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Completed

NCT Number: NCT06052982

Evaluation of Blood Loss During Knee Arthroplasty

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.

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Key information

Conditions

Primary Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drainage

Procedure

At the end of the knee arthroplasty, a drain is placed or not at the surgical site depending on randomization result

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assessment of blood transfusion during primary knee arthroplasty

    Time frame: from surgery until the 5th postoperative day

    Measurement of total blood transfused between surgery and the fifth day after surgery

  2. Number of patients with complications after knee arthroplasty in the two groups

    Time frame: From surgery up to the third month

    Monitoring for complications from surgery up to 3 months

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Registry information

Official study title

Comparative Randomized Study Evaluating Intra and Postoperative Total Blood Loss During Primary Knee Arthroplasty, With Drainage Versus Non-drainage

Acronym: SAD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2023
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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