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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Blood Loss
• Intervention / Treatment: Drug: Topical Solution; Drug: Topical Foam; Other: Topical

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Minia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tranexamic acid; Topical hemostatics as tranexamic acid or hydrogen peroxide in wound before skin closure to decrease perioperative blood loss	Drug: Topical Solution; Topical administration; Other Names: Irrigation; Drug: Topical Foam; Topical administration; Other Names: Disinfectant; Other: Topical; Topical administration; Other Names: Crystalloid
Active Comparator: Hydrogen peroxide; Topical hemostatics as hydrogen peroxide in wound before skin closure to decrease perioperative blood loss	Drug: Topical Solution; Topical administration; Other Names: Irrigation; Drug: Topical Foam; Topical administration; Other Names: Disinfectant; Other: Topical; Topical administration; Other Names: Crystalloid
Placebo Comparator: Normal saline; Hemostasis in spine surgery	Drug: Topical Solution; Topical administration; Other Names: Irrigation; Drug: Topical Foam; Topical administration; Other Names: Disinfectant; Other: Topical; Topical administration; Other Names: Crystalloid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss estimation [NCT ID not yet assigned]	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).	Within 48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Study Chair: Amani Khairy, Professor, Faculty of medicine, minia university; Study Director: Sarah Mohamed, Lecturer, Faculty of medicine, minia university; Study Director: Walid Zidan, Lecturer, Faculty of medicine, minia university; Principal Investigator: Nehal Kamal, Master, Faulty of medicine, Minia University

Publications and helpful links

General Publications

• Qureshi R, Puvanesarajah V, Jain A, Hassanzadeh H. Perioperative Management of Blood Loss in Spine Surgery. Clin Spine Surg. 2017 Nov;30(9):383-388. doi: 10.1097/BSD.0000000000000532.
• Hui S, Peng Y, Tao L, Wang S, Yang Y, Du Y, Zhang J, Zhuang Q; TARGETS study group. Tranexamic acid given into wound reduces postoperative drainage, blood loss, and hospital stay in spinal surgeries: a meta-analysis. J Orthop Surg Res. 2021 Jun 22;16(1):401. doi: 10.1186/s13018-021-02548-6.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Anti-Infective Agents; Disinfectants
• Other Study ID Numbers: blood loss in spine surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No