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

NCT05152186 | Unknown Phase 3

• 1 other identifier: blood loss in spine surgery
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of topical TXA in reducing blood loss compared to H2O2 wash. The primary outcomes :

1. 1.Estimation of Intraoperative blood loss and blood transfusion.
2. 2.Recording Postoperative blood drainage.
3. 3.Comparing Hemoglobin levels (pre and postoperative).
4. 4.Surgical site infection (SSI)
5. 5.Length of hospital stay.

Conditions

Blood Loss

Keywords

Blood loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications

  7 days

Study Arms (3)

tranexamic acid

ACTIVE COMPARATOR

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

Drug: Topical Solution; Drug: Topical Foam; Other: Topical

Hydrogen peroxide

ACTIVE COMPARATOR

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

Drug: Topical Solution; Drug: Topical Foam; Other: Topical

Normal saline

PLACEBO COMPARATOR

Hemostasis in spine surgery

Drug: Topical Solution; Drug: Topical Foam; Other: Topical

Interventions

Topical Solution DRUG

Topical administration

Also known as: Irrigation

Hydrogen peroxide; Normal saline; tranexamic acid

Topical Foam DRUG

Topical administration

Also known as: Disinfectant

Hydrogen peroxide; Normal saline; tranexamic acid

Topical OTHER

Topical administration

Also known as: Crystalloid

Hydrogen peroxide; Normal saline; tranexamic acid

Eligibility Criteria

• Age: 20 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University hospital

Minya, Egypt

Location

Related Publications (2)

• 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.

  PMID: 28338491 BACKGROUND

• 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.

  PMID: 34158096 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Solutions; Therapeutic Irrigation; Disinfectants; Crystalloid Solutions

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Isotonic Solutions

Study Officials

• Amani Khairy, Professor

  Faculty of Medicine, Minia University

  STUDY CHAIR

• Sarah Mohamed, Lecturer

  Faculty of Medicine, Minia University

  STUDY DIRECTOR

• Walid Zidan, Lecturer

  Faculty of Medicine, Minia University

  STUDY DIRECTOR

• Nehal Kamal, Master

  Faulty of medicine, Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 9, 2021
• Study Start: June 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)