Use of Tranexamic Acid in Blepharoplasties

NCT ID: NCT04724772

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2023-09-20

Brief Summary

The goal of this investigation is to assess whether or not there is a significant difference in the presence and/or degree of post-operative ecchymosis, pain, and edema between groups of patients undergoing upper lid blepharoplasty with traditional local anesthetic (LA) and those who receive tranexamic acid (TXA) in addition to traditional LA.

Detailed Description

Blood clot formation involves a cascade of reactions that results in the production of thrombin, which converts fibrinogen into fibrin. In turn, fibrin aggregates and forms a clot. Hemostasis depends on a balance between this clotting cascade and the processes that break down clots, particularly the conversion of plasminogen to plasmin and plasmin's subsequent degradation of fibrin polymers. Tranexamic acid (TXA) is an agent, first patented in 1957, that competitively inhibits plasmin generation and activity.

As a result, TXA promotes clotting and, therein, hemostasis, making it useful for controlling surgical bleeding. (See figure below.) Indeed, a 2012 meta-analysis demonstrated that administering TXA intra- or perioperatively reduces the probability of receiving a blood transfusion by one-third.

Additionally, large trials have shown that TXA does not increase the risk of thromboembolic events in patients. One study noted that there was a slightly increased incidence of seizures in patients who received TXA, though this was limited to patients who underwent open-heart surgery, which is, itself, an independent risk factor for seizures. Another study halved the dose of TXA administered to its participants, but this did not reduce seizure risk amongst the participants. Thus, the data on this adverse effect remains inconclusive, and surgeons continue using TXA for its hemostatic effects, especially in cardiac and orthopedic surgeries. Given that facial plastic surgery does not incur the same sort of blood loss as cardiac or orthopedic surgery, efforts to describe TXA use in this field have focused on its established anti-inflammatory properties in addition to hemostasis. There are reports of TXA use in rhinoplasties, face lifts, and blepharoplasties; however, such reports are scarce, with randomized, double-blinded, controlled clinical trials even more so. Only one study has examined TXA use in blepharoplasties. In that study, 34 patients were randomized to receive an injection of lidocaine mixed with either TXA or saline. The authors did not find any significant difference in post-operative parameters including size of periocular ecchymoses and patient-reported pain level. Since the only randomized controlled trial investigating TXA use in blepharoplasty involved 34 participants, the investigators aim to add to the body of knowledge on this matter.

Furthermore, the investigator's study will be structured differently from that of Sagiv et al. Firstly, the patients will serve as their own controls, since we will inject one eyelid with a solution containing TXA and another with a placebo solution. This will help reduce bias between study groups that may have existed in Sagiv et al's trial. Secondly, the investigators will follow the patients for 3 months after the procedure, which is eleven weeks longer than the duration of follow-up amongst participants in Sagiv et al's trial. This will give the investigators an even better sense of TXA's impact on patients' post-operative courses. In summary, the investigators wish to characterize TXA's hemostatic and anti-inflammatory effects in patients who undergo blepharoplasty. Since there is currently only one publication that accomplishes this, the investigators' objective is to expand knowledge in this area so that surgeons performing facial plastic procedures can optimize patients' recovery and outcomes.

Conditions

Pain, Postoperative; Bruising

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Blepharoplasty patient

Patient receives LA in one eye and LA with TXA in the other eye. They are blinded. They compare eyes without knowing which one received the TXA.

Group Type: EXPERIMENTAL

Tranexamic acid injection

Intervention Type: DRUG

Injection of tranexamic acid preoperatively

Interventions

Tranexamic acid injection

Injection of tranexamic acid preoperatively

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• any adult patient who is undergoing upper lid blepharoplasty with author Douglas Sidle, MD and who is older than 18 years of age, fluent in English, not on any anticoagulant or antiplatelet medication (e.g. aspirin, clopidogrel, etc.), not diagnosed with a coagulation disorder, not pregnant, not undergoing a simultaneous procedure, and not a Feinberg School of Medicine (FSM) student or Northwestern Memorial (NM) employee.

Exclusion Criteria

• less than 18 years of age, not fluent in English, taking anticoagulant or antiplatelet, has coagulation disorder, pregnant, simultaneous procedure, FSM or NM student/employee

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Douglas Sidle

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00211373

Identifier Type: -

Identifier Source: org_study_id