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This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with full-thickness rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No tranexamic acid; arthroscopic rotator cuff repair performed with plain normal-saline irrigation. | |
| Intra-articular TXA | Experimental | Tranexamic acid 500 mg added to each 1 L of normal-saline irrigation fluid during arthroscopic rotator cuff repair. |
|
| Intravenous TXA | Experimental | Tranexamic acid 1000 mg administered intravenously 10 minutes before surgery; plain normal-saline irrigation as in the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid (intra-articular) | Drug | 500 mg of tranexamic acid added per 1 L of normal-saline irrigation fluid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative visual clarity | Surgeon-rated clarity of the arthroscopic surgical field on a 0-10 numeric scale (0 = poorest visualization, 10 = optimal visualization), scored at the end of each of six surgical stages: glenohumeral procedure, subacromial bursectomy, acromioplasty, rotator cuff inspection, medial-row repair, and lateral-row repair. | Intraoperatively, at the end of each of the six surgical stages |
| Measure | Description | Time Frame |
|---|---|---|
| Total operative time | Total duration of the surgical procedure. | Intraoperative (duration of surgery) |
| Estimated blood loss | Estimated blood loss calculated from serum hemoglobin measured before and after surgery using the formula described by Good et al. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seok Won Chung, MD | Konkuk University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | Seoul | 05030 | South Korea |
There is no plan to share individual participant data.
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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The operating surgeon (outcome assessor) and the patient were blinded to group allocation. Study drug and irrigation fluid were prepared in a separate room by a circulating nurse; only the anesthesia team administering the intravenous agent was aware of allocation.
| Tranexamic acid (intravenous) | Drug | 1000 mg of tranexamic acid administered intravenously 10 minutes before surgery. |
|
| From immediately before surgery to immediately after the end of surgery |
| Irrigation-fluid volume | Total volume of irrigation fluid used during the procedure. | Intraoperatively, from skin incision to skin closure (duration of surgery) |
| Number of irrigation-pressure increases | Number of times the irrigation pump pressure was increased to control bleeding affecting the surgical field | Intraoperatively, from skin incision to skin closure (duration of surgery) |
| Postoperative shoulder swelling | Shoulder circumference and diameter measured at the axillary and deltoid sites with the arm abducted ~30 degrees, compared between pre-operative and postoperative day 1 | Baseline (pre-operative) and postoperative day 1 |
| Postoperative pain | Pain assessed using a visual analog scale (VAS) on postoperative day 1 | Pain assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse outcome, on postoperative day 1 |