Rotator Cuff TearsNCT04025736
Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid
A study testing Tranexamic Acid 100Mg/Ml Inj Vil 10Ml and 0.9% Sodium Chloride Injection in people with Rotator Cuff Tears and Shoulder Arthorscopy Surgery, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Shoulder Arthorscopy Surgery, Surgical Blood Loss
- What is being tested?
- Tranexamic Acid 100Mg/Ml Inj Vil 10Ml and 0.9% Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jun 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Tranexamic Acid 100Mg/Ml Inj Vil 10Ml, 0.9% Sodium Chloride Injection
- Keywords
- Tranexamic Acid, Shoulder Arthroscopy, Visual Clarity, Hemostasis
- Medical subject headings
- Rotator Cuff Injuries, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 100Mg/Ml Inj Vil 10MlDrug
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.
0.9% Sodium Chloride InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients received Tranexamic acid | Experimental | 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. Receives: Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml |
| Patients received same volume of saline | Placebo comparator | In the control group, the patient received 20ml saline intravenous also 10 min before surgery. Receives: Drug: 0.9% Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Measure the percentage of grade 3 visual clarity after surgery through study completion, an average of 1 year.
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
Measured: Measure the whole surgery's mean visual clarity grade after surgery through study completion, an average of 1 year.
Secondary outcomes (3)
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.
Measured: measure on post operative day one's morning through study completion, an average of 1 year.
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),
Measured: measure on post operative day one's morning through study completion, an average of 1 year.
change of serum hemoglobin before and after operation
use the change of Hb to calculate estimate blood loss by Gross formula.
Measured: measure on post operative day one's morning through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start7 Jun 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025736
- Sponsor's protocol ID
- A-BR-106-017
- Status last verified
- Jul 2019
- First submitted
- 14 Jul 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 26524933Karaaslan 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.
PubMed 26337246Felli 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.
PubMed 30611343Kirsch 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.
PubMed 28902659
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04025736
- Acronym / sponsor ID
- A-BR-106-017
- Keywords
- Tranexamic Acid, Shoulder Arthroscopy, Visual Clarity, Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients received Tranexamic acid | Experimental | Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10MlThe 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. |
| Patients received same volume of saline | Placebo comparator | Drug: 0.9% Sodium Chloride InjectionIn the control group, the patient received 20ml saline intravenous also 10 min before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid 100Mg/Ml Inj Vil 10MlTranexamic 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. | Drug | Patients received Tranexamic acid |
| 0.9% Sodium Chloride InjectionNormal 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. | Drug | Patients received same volume of saline |
Primary outcome
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).
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
3 secondary outcomes
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.
post operation shoulder swelling
Time frame: measure on post operative day one's morning through study completion, an average of 1 year.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Results publication: PubMed 26524933van 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 publication: PubMed 26337246Karaaslan 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 publication: PubMed 30611343Felli 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 publication: PubMed 28902659Kirsch 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid 100Mg/Ml Inj Vil 10Ml and 0.9% Sodium Chloride Injection in people with Rotator Cuff Tears and Shoulder Arthorscopy Surgery, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025736, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.