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Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

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ClinicalTrials.gov Identifier: NCT04025736
Recruitment Status : Completed
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Brief Summary:

Purpose: The study aimed to determine whether intravenous administration of tanexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity. Methods: This is a prospective, double-blinded, randomized and placebo-controlled study. From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair were enrolled and randomly assigned to either the TXA group that received 1000mg tranexamic acid intravenously 10 minutes before surgery or the placebo group that received the same volume of plain saline. Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anti-coagulation medications were excluded. The visual clarity was rated by a numeric rating scale from grade

1(poor) to grade 3(clear) every 15 minutes throughout the surgery. Secondary outcomes included estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration and associated comorbidities were recorded. Both parametric and nonparametric methods were used for statistical analysis.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Shoulder Arthorscopy Surgery Surgical Blood Loss Tranexamic Acid Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml Drug: 0.9% Sodium Chloride Injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Inclusion criteria were Patients who were diagnosed with rotator cuff tear and failure of conservative treatment for more than 3 months. The tear size was measured by MRI and must be repairable. We excluded patients who did not provide permit, those had history of coagulopathy, who were under anticoagulation therapy before surgery, who had abnormal coagulation profile (prothrombin time or activated partial thromboplastin time) before surgery, who had renal or liver disorder, those who had uncontrolled hypertension (systolic pressure >180 mmHg), or who were allergy to local anesthetic agent or Tranexamic acid.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-blind and Randomized Controlled Trial
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients received Tranexamic acid
The patient was assigned as intervention group, TXA will be aspirated into a syringe. In TXA group, TXA 1000 mg (20 mL) was given intravenously 10 minutes before surgery.
Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
Tranexamic acid (TXA) is a synthetic analog of the amino acid lysine which acts by competitively blocking the plasminogen lysine-binding site and inhibiting fibrinolysis. Several studies showed that TXA could reduce both blood loss and the amount of blood transfusion after shoulder arthroplasty surgeries.

Placebo Comparator: Patients received same volume of saline
In the control group, the patient received 20ml saline intravenous also 10 min before surgery.
Drug: 0.9% Sodium Chloride Injection
Normal saline is a mixture of sodium chloride in water and has a number of uses in medicine. We use the same volume of normal saline as placebo.




Primary Outcome Measures :
  1. Visual clarity during shoulder arthroscopic surgery. [ Time Frame: Measure the percentage of grade 3 visual clarity after surgery through study completion, an average of 1 year. ]
    We use 3-grades visual clarity. grade 1 means poor visual clarity; 2 means fair clarity and 3 means good clarity. The visual clarity was scored in every 15 minutes during the operation scoring system to evaluate visual clarity during arthroscopic surgery. 4 Grade 1 means poor visibility (active bleeding that the vision was too poor to perform the operation); Grade 2 means fair visibility (minor bleeding that can interfere vision but surgery can still perform); Grade 3 means good visibility (clear vision without obvious blood).

  2. Visual clarity during shoulder arthroscopic surgery. [ Time Frame: Measure the whole surgery's mean visual clarity grade after surgery through study completion, an average of 1 year. ]
    We use 3-grades visual clarity. grade 1 means poor visual clarity; 2 means fair clarity and 3 means good clarity. The visual clarity was scored in every 15 minutes during


Secondary Outcome Measures :
  1. patients' visual analog scale (VAS ) pain score on postoperative day 1 [ Time Frame: measure on post operative day one's morning through study completion, an average of 1 year. ]
    The visual analog scale(VAS) for pain is a continuous scale comprised of a horizontal line, which was 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme (from 0 cm means no pain to 10cm means worst pain possible) for patients self-assessment of pain.

  2. post operation shoulder swelling [ Time Frame: measure on post operative day one's morning through study completion, an average of 1 year. ]
    (compared the circumference of shoulder post op day 1 to the day of admission which were measured at two sites: axillary and deltoid),

  3. change of serum hemoglobin before and after operation [ Time Frame: measure on post operative day one's morning through study completion, an average of 1 year. ]
    use the change of Hb to calculate estimate blood loss by Gross formula.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who were diagnosed with rotator cuff tear and failure of conservative treatment for more than 3 months. The tear size was measured by MRI and must be repairable.

Exclusion Criteria:

  • Acute traumatic rotator cuff tear.
  • History of coagulopathy
  • Under anticoagulation therapy before surgery
  • Abnormal coagulation profile (prothrombin time or activated partial thromboplastin time) before surgery
  • Renal or liver disorder
  • Uncontrolled hypertension (baseline systolic pressure >180 mmHg)
  • Allergy to local anesthetic agent or TXA.

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): NCT04025736


Locations
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Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Sponsors and Collaborators
National Cheng-Kung University Hospital

Publications of Results:
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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT04025736     History of Changes
Other Study ID Numbers: A-BR-106-017
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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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 National Cheng-Kung University Hospital:
Tranexamic Acid
Shoulder Arthroscopy
Visual Clarity
Hemostasis
Additional relevant MeSH terms:
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Tranexamic Acid
Blood Loss, Surgical
Rotator Cuff Injuries
Hemorrhage
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Intraoperative Complications
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants