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

Phase 3

• Conditions: Blood Loss
• Interventions: Drug: Topical Solution; Drug: Topical Foam; Other: Topical

• Registration Number: NCT05152186
• Lead Sponsor: Minia University

Brief 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 .

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-11-01
• Study First Submitted: 2021-11-12
• Status Verified: 2021-12
• Study Completion: 2021-12-01
• Study First Submitted QC: 2021-12-07
• Last Update Submitted: 2021-12-07
• Study First Posted: 2021-12-09
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• ASA: class II or III
• Sex: male and female
• Age: from 20 to 70 years.
• Type of operation: patient will undergo spinal surgery with a diagnosis of in place spinal trauma, thoracic or lumbar degenerative disease, such as spinal canal stenosis, disc herniation, spondylolisthesis, and/or degenerative scoliosis under general anesthesia.

Exclusion Criteria

• Patients with history of thromboembolic disease or coagulopathy or hereditary bleeding disorders such as factor VIII deficiency, factor IX deficiency, and Von-Willebrand disease.
• Patients who were taking anticoagulants or antiplatelet drugs.
• Allergy or hypersensitivity to TXA.
• A dural tear accompanied by cerebrospinal fluid leakage detected intraoperatively.
• Spinal cord tumors, head trauma and penetrating spinal cord trauma.
• The use of intravenous TXA during the perioperative period .
• Infection at the operative site e.g T.B.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tranexamic acid	Topical Solution	Topical hemostatics as tranexamic acid or hydrogen peroxide in wound before skin closure to decrease perioperative blood loss
tranexamic acid	Topical Foam	Topical hemostatics as tranexamic acid or hydrogen peroxide in wound before skin closure to decrease perioperative blood loss
Hydrogen peroxide	Topical Foam	Topical hemostatics as hydrogen peroxide in wound before skin closure to decrease perioperative blood loss
Normal saline	Topical Foam	Hemostasis in spine surgery
tranexamic acid	Topical	Topical hemostatics as tranexamic acid or hydrogen peroxide in wound before skin closure to decrease perioperative blood loss
Hydrogen peroxide	Topical Solution	Topical hemostatics as hydrogen peroxide in wound before skin closure to decrease perioperative blood loss
Normal saline	Topical	Hemostasis in spine surgery
Hydrogen peroxide	Topical	Topical hemostatics as hydrogen peroxide in wound before skin closure to decrease perioperative blood loss
Normal saline	Topical Solution	Hemostasis in spine surgery

Primary Outcome Measures

Name	Time	Method
Blood loss estimation [NCT ID not yet assigned]	Within 48 hours	Estimation of perioperative blood loss and need of blood transfusion, lab investigations pre and postoperative (hemoglobin (gm/dL), hematocrit (%), Prothrombin concentration (%), INR, platelets).; * Recording Postoperative blood drainage (in ml). and Comparing Hemoglobin levels (pre and postoperative).

Secondary Outcome Measures

Name	Time	Method
Complications	7 days	Anaemia secondary to blood loss, surgical site infection , length of hospital stay (in days), complications of drugs used in procedure.

Trial Locations

Locations (1)

Minia University hospital; 🇪🇬 Minya, Egypt