Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid
Primary Purpose
Rotator Cuff Tears, Shoulder Arthorscopy Surgery, Surgical Blood Loss
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
0.9% Sodium Chloride Injection
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Tranexamic Acid, Shoulder Arthroscopy, Visual Clarity, Hemostasis
Eligibility 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.
Sites / Locations
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Patients received Tranexamic acid
Patients received same volume of saline
Arm Description
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.
In the control group, the patient received 20ml saline intravenous also 10 min before surgery.
Outcomes
Primary Outcome Measures
Visual clarity during shoulder arthroscopic surgery.
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).
Visual clarity during shoulder arthroscopic surgery.
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
patients' visual analog scale (VAS ) pain score on postoperative day 1
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.
post operation shoulder swelling
(compared the circumference of shoulder post op day 1 to the day of admission which were measured at two sites: axillary and deltoid),
change of serum hemoglobin before and after operation
use the change of Hb to calculate estimate blood loss by Gross formula.
Full Information
NCT ID
NCT04025736
First Posted
July 14, 2019
Last Updated
July 17, 2019
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04025736
Brief Title
Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Shoulder Arthorscopy Surgery, Surgical Blood Loss, Tranexamic Acid
Keywords
Tranexamic Acid, Shoulder Arthroscopy, Visual Clarity, Hemostasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients received Tranexamic acid
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients received same volume of saline
Arm Type
Placebo Comparator
Arm Description
In the control group, the patient received 20ml saline intravenous also 10 min before surgery.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride Injection
Intervention Description
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 Measure Information:
Title
Visual clarity during shoulder arthroscopic surgery.
Description
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).
Time Frame
Measure the percentage of grade 3 visual clarity after surgery through study completion, an average of 1 year.
Title
Visual clarity during shoulder arthroscopic surgery.
Description
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
Time Frame
Measure the whole surgery's mean visual clarity grade after surgery through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
patients' visual analog scale (VAS ) pain score on postoperative day 1
Description
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.
Time Frame
measure on post operative day one's morning through study completion, an average of 1 year.
Title
post operation shoulder swelling
Description
(compared the circumference of shoulder post op day 1 to the day of admission which were measured at two sites: axillary and deltoid),
Time Frame
measure on post operative day one's morning through study completion, an average of 1 year.
Title
change of serum hemoglobin before and after operation
Description
use the change of Hb to calculate estimate blood loss by Gross formula.
Time Frame
measure on post operative day one's morning through study completion, an average of 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
26524933
Citation
van Montfoort DO, van Kampen PM, Huijsmans PE. Epinephrine Diluted Saline-Irrigation Fluid in Arthroscopic Shoulder Surgery: A Significant Improvement of Clarity of Visual Field and Shortening of Total Operation Time. A Randomized Controlled Trial. Arthroscopy. 2016 Mar;32(3):436-44. doi: 10.1016/j.arthro.2015.08.027.
Results Reference
result
PubMed Identifier
26337246
Citation
Karaaslan F, Karaoglu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2720-6. doi: 10.1177/0363546515599629. Epub 2015 Sep 2.
Results Reference
result
PubMed Identifier
30611343
Citation
Felli L, Revello S, Burastero G, Gatto P, Carletti A, Formica M, Alessio-Mazzola M. Single Intravenous Administration of Tranexamic Acid in Anterior Cruciate Ligament Reconstruction to Reduce Postoperative Hemarthrosis and Increase Functional Outcomes in the Early Phase of Postoperative Rehabilitation: A Randomized Controlled Trial. Arthroscopy. 2019 Jan;35(1):149-157. doi: 10.1016/j.arthro.2018.07.050.
Results Reference
result
PubMed Identifier
28902659
Citation
Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021.
Results Reference
result
Learn more about this trial
Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid
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