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Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy

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ClinicalTrials.gov Identifier: NCT03954860
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Brief Summary:
The objective of this study was to evaluate the safety and efficacy of topical combined with intravenous tranexamic acid for high tibial osteotomy without placement of a drainage tube The clinical scores of patients and their possible risks were tracked. The investigators hypothesized that a combination of tranexamic acid and no drainage tube could reduce blood loss and facilitate early recovery. The implementation of the study will provide a new perioperative blood loss control program for High Tibial Osteotomy, reduce the cost of hospitalization, promote patients to get out of bed early, reduce the number of days in hospital.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: Drainage Tube Drug: Tranexamic Acid Drug: Sodium Chloride 0.9% Not Applicable

Detailed Description:
The condition of the patients was evaluated, and the total length of both lower limbs, anteroposterior position of knee and Mri of knee were included. The preoperative dose of tranexamic acid was calculated according to body weight of 20 mg / kg, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 1.2 g of diluted saline solution containing tranexamic acid was dripped 20 ml before loosening tourniquet Postoperative intravenous drip of 100 ML sodium chloride solution containing 0.8 g tranexamic acid. Arthroscopy was first used to further confirm the cartilage defect, and a new type of lower limb alignment meter and a customized precise osteotomy template were used to perform the osteotomy according to the preoperative plan. One group was not placed drainage tube, the other group was placed drainage tube. Visual analogue pain score (Vas) and American Special Surgical Hospital (HSS) knee function score were recorded 1 month after surgery. Throughout the trial, the investigators will carefully observe and manage your complications and the outcome of your surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : May 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: No Drainage
The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 20 ml saline containing 1.2 g tranexamic acid was applied to the local area before loosening the tourniquet Postoperative intravenous drip of 100 ML sodium chloride solution containing 0.8 g tranexamic acid. No drainage tube was placed after operation.
Drug: Tranexamic Acid
Tranexamic acid (TXA) is an anti-fibrinolytic drugcan,which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.
Other Name: TXA

Drug: Sodium Chloride 0.9%
Sodium Chloride 0.9% is a solution of sodium chloride, which has the same osmotic pressure as animal or human plasma in physiological experiments or clinics, and can be used to dilute Tranexamic Acid .
Other Name: sodium chloride solution

Active Comparator: Drainage
The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 20 ml saline containing 1.2 g tranexamic acid was applied to the local area before loosening the tourniquet Postoperative intravenous drip of 100 ML sodium chloride solution containing 0.8 g tranexamic acid. Drainage tube should be placed after operation.
Other: Drainage Tube
The drainage tube drainage to guide the pus, blood and liquid accumulated between human tissues or in body cavity outside the body of High tibial osteotomy'patients.

Drug: Tranexamic Acid
Tranexamic acid (TXA) is an anti-fibrinolytic drugcan,which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.
Other Name: TXA

Drug: Sodium Chloride 0.9%
Sodium Chloride 0.9% is a solution of sodium chloride, which has the same osmotic pressure as animal or human plasma in physiological experiments or clinics, and can be used to dilute Tranexamic Acid .
Other Name: sodium chloride solution




Primary Outcome Measures :
  1. Postoperative blood loss [ Time Frame: The day after the operation ]
    Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.

  2. Haemoglobin [ Time Frame: The day after the operation ]
    Reactive blood loss

  3. Hematocrit [ Time Frame: The day after the operation ]
    Reactive blood loss

  4. Activated partial thromboplastin time [ Time Frame: The day after the operation ]
    Assessment of coagulation function in patients

  5. Prothrombin time [ Time Frame: The day after the operation ]
    Assessment of exogenous coagulation system

  6. Concentration of D-dimer [ Time Frame: The day after the operation ]
    Assessment of thrombotic diseases

  7. Concentration of Fibrinogen [ Time Frame: The day after the operation ]
    Assessment of coagulation function in patients

  8. Hospital for special surgery knee score [ Time Frame: postoperative 1 month ]
    HSS is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.

  9. Color doppler ultrasound of lower limb blood vessel [ Time Frame: Through study completion, an average of 1 year ]
    To determine if any thrombosis were formed

  10. Visual Analogue Scale Postoperative Day One [ Time Frame: Postoperative Day One ]
    Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.

  11. Visual Analogue Scale Postoperative Day Two [ Time Frame: Postoperative Day Two ]
    Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.

  12. Visual Analogue Scale Postoperative Day Three [ Time Frame: Postoperative Day Three ]
    Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.


Secondary Outcome Measures :
  1. Circumference of shank Postoperative Day One [ Time Frame: Postoperative Day One ]
    indirectly reflects the latent blood loss

  2. Circumference of shank Postoperative Day Two [ Time Frame: Postoperative Day Two ]
    indirectly reflects the latent blood loss

  3. Circumference of shank Postoperative Day Three [ Time Frame: Postoperative Day Three ]
    indirectly reflects the latent blood loss



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. be in good physical condition and able to tolerate surgery;
  2. according to the diagnostic criteria ("diagnostic criteria of Osteoarthritis" , Chinese Society of Rheumatology, 2010) , patients with knee osteoarthritis were definitely diagnosed;
  3. the presence of significant extraarticular deformity;
  4. The contralateral compartment had good cartilage;
  5. the course of diagnosis of Gonarthritis was more than 6 months
  6. informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process

Exclusion Criteria:

  1. patients with acute joint injury, tuberculosis of the knee joint, tumor, rheumatism and rheumatoid knee arthritis;
  2. patients with serious primary diseases such as heart, brain, blood vessel, liver, kidney and hemopoietic system, mental disease;
  3. allergic constitution and drug allergy to tranexamic acid;
  4. having uncontrolled infection during the active period (positive for HIV, hepatitis B and Hepatitis C virus) ;
  5. other open operations related to knee manipulation within 6 months;
  6. prior to this study, subjects were subjected to other clinical trials;
  7. failure to meet the inclusion criteria, failure to comply with the protocol, inability to assess efficacy, or incomplete information that affects efficacy or safety assessment.

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): NCT03954860


Contacts
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Contact: songlin Li, bachelor 053182166541 ext 0086 bysonglin@126.com

Locations
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China, Shandong
Qilu hospital of Shandong University Recruiting
Jinan, Shandong, China, 250014
Contact: songlin Li, MD    15634057227    bysonglin@126.com   
Sponsors and Collaborators
Qilu Hospital of Shandong University
Investigators
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Study Chair: Peilai Liu, Ph.D Qilu Hospital of Shandong University

Publications:

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Responsible Party: Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT03954860     History of Changes
Other Study ID Numbers: 2019041
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pharmaceutical Solutions
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants