Clinical trial NCT05152186: Compare Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Blood Loss in Spine Surgeries
Official title: Comparison Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Perioperative Blood Loss in Elective Spine Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Blood Loss
Keywords: Blood loss
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 .

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.

Primary outcomes:
measure: Blood loss estimation [NCT ID not yet assigned]
timeFrame: Within 48 hours
Secondary outcomes:
measure: Complications
timeFrame: 7 days
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University hospital
Study officials:
affiliation: Faculty of Medicine, Minia University
name: Amani Khairy, Professor
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Minia University
name: Sarah Mohamed, Lecturer
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Minia University
name: Walid Zidan, Lecturer
role: STUDY_DIRECTOR
affiliation: Faulty of medicine, Minia University
name: Nehal Kamal, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.