Compare Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Blood Loss in Spine Surgeries (Bloodloss)
Primary Purpose
Blood Loss
Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Topical Solution
Topical Foam
Topical
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss focused on measuring Blood loss
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.
Sites / Locations
- Minia University hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
tranexamic acid
Hydrogen peroxide
Normal saline
Arm Description
Topical hemostatics as tranexamic acid or hydrogen peroxide in wound before skin closure to decrease perioperative blood loss
Topical hemostatics as hydrogen peroxide in wound before skin closure to decrease perioperative blood loss
Hemostasis in spine surgery
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Complications
Anaemia secondary to blood loss, surgical site infection , length of hospital stay (in days), complications of drugs used in procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05152186
Brief Title
Compare Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Blood Loss in Spine Surgeries
Acronym
Bloodloss
Official Title
Comparison Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Perioperative Blood Loss in Elective Spine Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effectiveness of topical TXA in reducing blood loss compared to H2O2 wash.
The primary outcomes :
Estimation of Intraoperative blood loss and blood transfusion.
Recording Postoperative blood drainage.
Comparing Hemoglobin levels (pre and postoperative).
The secondary outcomes :
Surgical site infection (SSI)
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
Blood loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tranexamic acid
Arm Type
Active Comparator
Arm Description
Topical hemostatics as tranexamic acid or hydrogen peroxide in wound before skin closure to decrease perioperative blood loss
Arm Title
Hydrogen peroxide
Arm Type
Active Comparator
Arm Description
Topical hemostatics as hydrogen peroxide in wound before skin closure to decrease perioperative blood loss
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Hemostasis in spine surgery
Intervention Type
Drug
Intervention Name(s)
Topical Solution
Other Intervention Name(s)
Irrigation
Intervention Description
Topical administration
Intervention Type
Drug
Intervention Name(s)
Topical Foam
Other Intervention Name(s)
Disinfectant
Intervention Description
Topical administration
Intervention Type
Other
Intervention Name(s)
Topical
Other Intervention Name(s)
Crystalloid
Intervention Description
Topical administration
Primary Outcome Measure Information:
Title
Blood loss estimation [NCT ID not yet assigned]
Description
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).
Time Frame
Within 48 hours
Secondary Outcome Measure Information:
Title
Complications
Description
Anaemia secondary to blood loss, surgical site infection , length of hospital stay (in days), complications of drugs used in procedure.
Time Frame
7 days
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amani Khairy, Professor
Organizational Affiliation
Faculty of Medicine, Minia University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sarah Mohamed, Lecturer
Organizational Affiliation
Faculty of Medicine, Minia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Walid Zidan, Lecturer
Organizational Affiliation
Faculty of Medicine, Minia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nehal Kamal, Master
Organizational Affiliation
Faulty of medicine, Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minia University hospital
City
Minya
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28338491
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.
Results Reference
background
PubMed Identifier
34158096
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.
Results Reference
background
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Compare Between the Effect of Topical Tranexamic Acid Versus Hydrogen Peroxide on Blood Loss in Spine Surgeries
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