NCT05152186

Compare Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Blood Loss in Spine Surgeries

Comparison Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Perioperative Blood Loss in Elective Spine Surgeries

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness of topical TXA in reducing blood loss compared to H2O2 wash. The primary outcomes : 1. Estimation of Intraoperative blood loss and blood transfusion. 2. Recording Postoperative blood drainage. 3. Comparing Hemoglobin levels (pre and postoperative). The secondary outcomes : 1. Surgical site infection (SSI) 2. Length of hospital stay.

Detailed description

Spinal surgery is one of the most commonly performed neuro-surgeries worldwide. Massive blood loss occurs frequently and remains a challenge in complex spinal surgery. Significant intra and postoperative hemorrhage negatively affects patient outcomes by increasing coagulopathy, postoperative hematoma and anemia .The need for allogenic blood transfusions can lead to potential transfusion reactions and infections, in addition to increasing long-term mortality rates. There is an economic disadvantage associated with iatrogenic major blood loss relating to the direct costs of the blood products and intraoperative blood salvage technology and indirect costs of prolonged patient hospitalization and complication management . Many efforts have focused on achieving better perioperative blood conservation, in particular through prophylactic intravenous administration of antifibrinolytic agents before and during major surgery. Intravenous administration of the inexpensive but highly effective drug as tranexamic acid (TXA) reduces perioperative hemorrhage and the need for blood transfusions by one third in major surgery, including spinal surgery, Included on the list of the World Health Organization (WHO) List of Essential Medicines, TXA has taken its place as a widely used hemostatic agent in the clinical setting . Tranexamic acid is a synthetic analog of the amino acid lysine. It serves as an antifibrinolytic by reversibly binding four to five lysine receptor sites on plasminogen. This reduces conversion of plasminogen to plasmin, preventing fibrin degradation and preserving the framework of fibrin's matrix structure .Tranexamic acid has roughly eight times the antifibrinolytic activity of an older analogue, ε-aminocaproic acid. Tranexamic acid also directly inhibits the activity of plasmin with weak potency . Hydrogen peroxide (H2O2) is an inexpensive and readily available option whose hemostatic and antiseptic properties have been separately confirmedin several previous studies .

Conditions

• Blood Loss

Interventions

Type	Name	Description
DRUG	Topical Solution	Topical administration
DRUG	Topical Foam	Topical administration
OTHER	Topical	Topical administration

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2021-12-09
• Last updated: 2021-12-09

Locations

1 site across 1 country: Egypt