Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-04
Brief Title:
The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery - a Prospective Multicenter Randomized Double-blinded Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tranexamic acid is a synthetic reversible competitive inhibitor to plasminogen lysine receptor which prevents plasmin formation and stabilizes the fibrin matrix thus reducing bleeding While recent studies have demonstrated the antifibrinolytic benefits of TXA in obstetric and gynecologic conditions traumatic hemorrhage cardiac surgery total knee arthroplasty and more there is a paucity of clinical data on TXA use in plastic surgery The aim of this study is to evaluate the effect of local and systemic TXA on postoperative periocular ecchymosisedema in orbital surgery
Detailed Description:
Patients who will be undergoing orbital surgery anyways will be given the option to participate in the study Informed consent will be obtained in clinic during the preoperative consultation On the day of surgery in the preoperative suite study participants will be randomly allocated to one of three groups via computer-generated random numbers
Group 1 will receive 1g intravenous tranexamic acid Pfizer New York NY 20 minutes prior to surgery Group 2 will receive 17 mL of subcutaneous tranexamic acid 100 mgmL Pfizer New York NY with local anesthetic to the orbit two minutes prior to incision Group 3 will receive intravenous normal saline and subcutaneous local anesthetic ie standard procedure as control group
Twenty minutes before incision time all patients will receive an intravenous solution This will be either saline placebo participants in group 2 and 3 or 1g of tranexamic acid participants in group 1 All operations will be performed using the standard of care technique and surgical instruments All surgery will be performed under intravenous sedation with local anesthesia Standard skin marking will be drawn then the surgeon will inject each patient subcutaneously with either 1 a 5 cc mixture of TXA 100 mgmL mixed with 2 lidocaine with epinephrine and 05 marcaine with epinephrine in a 111 ratio local TXA Group 2 or 2 normal saline 09 sodium chloride mixed with 2 lidocaine with epinephrine and 05 marcaine with epinephrine in a 111 ratio Group 1 Group 3 Degree of ecchymosis and edema in the postoperative photographs will be assessed separately by two graders Graders will be blinded to treatment groups and the photos will be completely deidentified
Immediately following the procedure the surgeon will take standardized photographs The surgeon will also take standardized photographs at the regular 7-day postoperative visit These photos will be deidentified and analyzed for degree of ecchymosis and edema by two blinded graders who will rate the photos using a standard five point grading scale 0 none 1 mild 2 moderate 3 severe 4 profound as described in the respective outcome measures
Group 1 will receive 1g intravenous tranexamic acid Pfizer New York NY 20 minutes prior to surgery Group 2 will receive 17 mL of subcutaneous tranexamic acid 100 mgmL Pfizer New York NY with local anesthetic to the orbit two minutes prior to incision Group 3 will receive intravenous normal saline and subcutaneous local anesthetic ie standard procedure as control group
Twenty minutes before incision time all patients will receive an intravenous solution This will be either saline placebo participants in group 2 and 3 or 1g of tranexamic acid participants in group 1 All operations will be performed using the standard of care technique and surgical instruments All surgery will be performed under intravenous sedation with local anesthesia Standard skin marking will be drawn then the surgeon will inject each patient subcutaneously with either 1 a 5 cc mixture of TXA 100 mgmL mixed with 2 lidocaine with epinephrine and 05 marcaine with epinephrine in a 111 ratio local TXA Group 2 or 2 normal saline 09 sodium chloride mixed with 2 lidocaine with epinephrine and 05 marcaine with epinephrine in a 111 ratio Group 1 Group 3 Degree of ecchymosis and edema in the postoperative photographs will be assessed separately by two graders Graders will be blinded to treatment groups and the photos will be completely deidentified
Immediately following the procedure the surgeon will take standardized photographs The surgeon will also take standardized photographs at the regular 7-day postoperative visit These photos will be deidentified and analyzed for degree of ecchymosis and edema by two blinded graders who will rate the photos using a standard five point grading scale 0 none 1 mild 2 moderate 3 severe 4 profound as described in the respective outcome measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None