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Evaluation of Blood Loss During Knee Arthroplasty (SAD)

Primary Purpose

Primary Knee Arthroplasty

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Drainage
Sponsored by
Groupe Hospitalier Diaconesses Croix Saint-Simon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Primary Knee Arthroplasty focused on measuring Blood, Loss, Drainage, Without drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groupe Hospitalier Diaconesses Croix Saint Simon

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Drain

Without drain

Arm Description

At the end of the knee arthroplasty, a drain is placed at the surgical site

At the end of the knee arthroplasty, a drain is not placed at the surgical site

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assessment of blood transfusion during primary knee arthroplasty
Measurement of total blood transfused between surgery and the fifth day after surgery
Number of patients with complications after knee arthroplasty in the two groups
Monitoring for complications from surgery up to 3 months

Full Information

First Posted
March 23, 2023
Last Updated
September 19, 2023
Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
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1. Study Identification

Unique Protocol Identification Number
NCT06052982
Brief Title
Evaluation of Blood Loss During Knee Arthroplasty
Acronym
SAD
Official Title
Comparative Randomized Study Evaluating Intra and Postoperative Total Blood Loss During Primary Knee Arthroplasty, With Drainage Versus Non-drainage
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
July 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Knee Arthroplasty
Keywords
Blood, Loss, Drainage, Without drainage

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
510 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drain
Arm Type
Other
Arm Description
At the end of the knee arthroplasty, a drain is placed at the surgical site
Arm Title
Without drain
Arm Type
Other
Arm Description
At the end of the knee arthroplasty, a drain is not placed at the surgical site
Intervention Type
Procedure
Intervention Name(s)
Drainage
Intervention Description
At the end of the knee arthroplasty, a drain is placed or not at the surgical site depending on randomization result
Primary Outcome Measure Information:
Title
Hemoglobin dosage and bleeding quantification in both groups
Description
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.
Time Frame
from the day before surgery until the 5th postoperative day
Secondary Outcome Measure Information:
Title
Assessment of blood transfusion during primary knee arthroplasty
Description
Measurement of total blood transfused between surgery and the fifth day after surgery
Time Frame
from surgery until the 5th postoperative day
Title
Number of patients with complications after knee arthroplasty in the two groups
Description
Monitoring for complications from surgery up to 3 months
Time Frame
From surgery up to the third month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc LHOTELLIER, MD
Organizational Affiliation
Groupe Hospitalier Diaconesses Croix Saint-Simon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Diaconesses Croix Saint Simon
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Blood Loss During Knee Arthroplasty

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