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Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915756
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Afonso Cardoso, Hospital Beatriz Ângelo

Brief Summary:
The investigator's aim with this study is to address, with the new paradigm of tranexamic acid, the role of wound drainage following total knee arthroplasty in blood loss, blood transfusion requirements and functional recovery

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: Drainage of surgical wound Not Applicable

Detailed Description:

All participants will attend a preoperatory appointment with an anaesthesiologist where preoperative haemoglobin will be optimized (Hg > 13 g/L).

Randomization will be done by opening a closed envelop with the selected group from a bag at the time of wound closure.

Collected preoperative information will include age, gender, weight, height, body-mass index, underlying diseases, operated side, haematocrit, haemoglobin level, midpatellar knee circumference and range of movement. Blood work was performed within 1 hour of the beginning of the surgery. Clinical parameters will be collected before anaesthesia.

In all cases, the surgeon will perform a medial parapatellar approach with a standard incision with the participants in the supine position. The SIGMA PFC total knee system (DePuy, Warsaw, In) and its posterior-stabilized design with a rotatory platform will be used. All participants will be under a subarachnoid spinal block.

A tourniquet will be used (pressure of 350 mmHg) from the beginning of the surgery and deflated for haemostasis before wound closure. At this time, before complete water-tight fascial closure, the patients will be allocated to group With or Without drain as described, and a drain will be placed in a subfascial position. The drain will be left clamped for 1 hour and will be left in place for 24 hours. Compressive dressings will be applied at the end of the surgery. Continuous passive motion will be started within 24 hours of surgery (0-60°, progressing as tolerated).

In all participants, about 30min before tourniquet release, intravenous tranexamic acid will be used with an initial bolus of 10 mg/kg administered in 10min followed by a perfusion of 10mg/kg over 4h. For postoperative analgesia, a femoral triangle and a popliteal block (anterior approach) will be done in all participants.

A standard fluid therapy of a balanced crystalloid solution (perfusion 10ml/kg/h) will be administered to all patients. After tourniquet release, during haemostasis and in the recovery room, an eventual need of increasing fluid therapy perfusion or a bolus will be noted in the patient's file.

Hidden blood loss will be calculated according to the haemoglobin balance method as it suggested to be the most reliable method. Total blood volume will be calculated as described by Nadler et al.

The normality of the data will be tested with the Shapiro-Wilk test/Kolmogorov-Smirnov test. The data will be compared and analyzed using Student's t-test for independent samples, or the Mann-Whitney test, according to the normality of the data. The correlation of data will be analyzed with the Pearson or Spearman correlation coefficient according to its normality. Nominal variables will be compared using the chi-square test. P-values less than 0.05 will be considered significant. Dedicated statistical software (SPSS version 21, SPSS Inc., Chicago, USA) will be used.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid: a Clinical Trial
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: With drain
Participants who received a drain during surgery
Procedure: Drainage of surgical wound
Introduction of a drain before full fascial closure

No Intervention: Without drain
Participants who did not receive a drain during surgery



Primary Outcome Measures :
  1. Total RBC loss [ Time Frame: 96 hours ]
    Total red blood cells loss after surgery

  2. Total RBC loss [ Time Frame: 24 hours ]
    Total red blood cells loss after surgery

  3. Total RBC loss [ Time Frame: 1 hour ]
    Total red blood cells loss after surgery

  4. Blood transfusion requirements [ Time Frame: 96 hours ]
    Blood transfusions requirements

  5. Knee Society Score score [ Time Frame: 14 days ]
    Knee Society Score measuring function of Knee (0-100 total score, higher values, better outcome)


Secondary Outcome Measures :
  1. Haematocrit level [ Time Frame: 1 hour ]
    Haematocrit level

  2. Haematocrit level [ Time Frame: 24 hours ]
    Haematocrit level

  3. Haematocrit level [ Time Frame: 96 hours ]
    Haematocrit level

  4. Haemoglobin level [ Time Frame: 1 hour ]
    Haemoglobin level

  5. Haemoglobin level [ Time Frame: 24 hours ]
    Haemoglobin level

  6. Haemoglobin level [ Time Frame: 96 hours ]
    Haemoglobin level

  7. Surgery duration [ Time Frame: 0hour ]
    Surgery duration (min)

  8. Length of skin incision [ Time Frame: 0 hour ]
    Length of skin incision

  9. Tourniquet duration [ Time Frame: 0 hour ]
    Tourniquet duration (min)

  10. Surgical blood loss [ Time Frame: 0 hour ]
    Surgical blood loss (mL)

  11. Iron [ Time Frame: 96 hours ]
    Iron products used

  12. Transfusion reactions [ Time Frame: 96 hours ]
    Transfusion reactions

  13. Drain volume [ Time Frame: 24 hours ]
    Drain volume (mL)

  14. MKC [ Time Frame: 48 hours ]
    Midpatellar Knee Circumference (cm)

  15. MKC [ Time Frame: 96 hours ]
    Midpatellar Knee Circumference (cm)

  16. MKC [ Time Frame: 14 days ]
    Midpatellar Knee Circumference (cm)

  17. ROM [ Time Frame: 48 hours ]
    Range of motion (°)

  18. ROM [ Time Frame: 96 hours ]
    Range of motion (°)

  19. ROM [ Time Frame: 14 days ]
    Range of motion (°)

  20. Fluidotherapy excess [ Time Frame: 96 hours ]
    Fluidotherapy excess (mL)

  21. Wound complications (i. e., wound dehiscence, infection) [ Time Frame: 14 days ]
    Wound complications (i. e., wound dehiscence, infection)

  22. Lower leg deep vein thrombosis [ Time Frame: 14 days ]
    Lower leg deep vein thrombosis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Consecutive patients admitted to perform a primary unilateral total knee arthroplasty

Exclusion Criteria:

  • Contraindication to take tranexamic acid
  • hematologic disease with a higher risk of bleeding
  • abnormal coagulation tests
  • refusal of blood transfusions
  • inadequate preoperatory optimization
  • deformity >15⁰ of varus or valgus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915756


Contacts
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Contact: Afonso Cardoso 00351918972882 afonso.cardoso@hbeatrizangelo.pt

Locations
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Portugal
Hospital Beatriz Angelo Recruiting
Loures, Portugal, 2674-514
Contact: Afonso Cardoso    00351918972882    afonso.cardoso@hbeatrizangelo.pt   
Sponsors and Collaborators
Hospital Beatriz Ângelo
Investigators
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Principal Investigator: Afonso Cardoso Hospital Beatriz Angelo
Publications:

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Responsible Party: Afonso Cardoso, Principal Investigator, Hospital Beatriz Ângelo
ClinicalTrials.gov Identifier: NCT03915756    
Other Study ID Numbers: 0389
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Afonso Cardoso, Hospital Beatriz Ângelo:
Knee replacement
Blood loss
Wound drainage
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases