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

NCT ID: NCT05152186

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-12-01

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 .

Conditions

Blood Loss

Keywords

Blood loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

tranexamic acid

Topical hemostatics as tranexamic acid or hydrogen peroxide in wound before skin closure to decrease perioperative blood loss

Group Type: ACTIVE_COMPARATOR

Topical Solution

Intervention Type: DRUG

Topical administration

Topical Foam

Intervention Type: DRUG

Topical administration

Topical

Intervention Type: OTHER

Topical administration

Hydrogen peroxide

Topical hemostatics as hydrogen peroxide in wound before skin closure to decrease perioperative blood loss

Group Type: ACTIVE_COMPARATOR

Topical Solution

Intervention Type: DRUG

Topical administration

Topical Foam

Intervention Type: DRUG

Topical administration

Topical

Intervention Type: OTHER

Topical administration

Normal saline

Hemostasis in spine surgery

Group Type: PLACEBO_COMPARATOR

Topical Solution

Intervention Type: DRUG

Topical administration

Topical Foam

Intervention Type: DRUG

Topical administration

Topical

Intervention Type: OTHER

Topical administration

Interventions

Topical Solution

Topical administration

Intervention Type: DRUG

Topical Foam

Topical administration

Intervention Type: DRUG

Topical

Topical administration

Intervention Type: OTHER

Other Intervention Names

Irrigation; Disinfectant; Crystalloid

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Nehal Kamal Mohamed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amani Khairy, Professor

Role: STUDY_CHAIR

Faculty of Medicine, Minia University

Sarah Mohamed, Lecturer

Role: STUDY_DIRECTOR

Faculty of Medicine, Minia University

Walid Zidan, Lecturer

Role: STUDY_DIRECTOR

Faculty of Medicine, Minia University

Nehal Kamal, Master

Role: PRINCIPAL_INVESTIGATOR

Faulty of medicine, Minia University

Locations

Minia University hospital

Minya, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 28338491 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34158096 (View on PubMed)

Other Identifiers

blood loss in spine surgery

Identifier Type: -

Identifier Source: org_study_id