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To evaluate the effectiveness of topical TXA in reducing blood loss compared to H2O2 wash.
The primary outcomes :
The secondary outcomes :
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tranexamic acid | Active Comparator | Topical hemostatics as tranexamic acid or hydrogen peroxide in wound before skin closure to decrease perioperative blood loss |
|
| Hydrogen peroxide | Active Comparator | Topical hemostatics as hydrogen peroxide in wound before skin closure to decrease perioperative blood loss |
|
| Normal saline | Placebo Comparator | Hemostasis in spine surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Solution | Drug | Topical administration |
|
| 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).
| Within 48 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amani Khairy, Professor | Minia University | Study Chair |
| Sarah Mohamed, Lecturer | Minia University | Study Director |
| Walid Zidan, Lecturer | Minia University | Study Director |
| Nehal Kamal, Master | Faulty of medicine, Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia University hospital | Minya | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28338491 | Background | 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. | |
| 34158096 | 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. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| D007507 | Therapeutic Irrigation |
| D004202 | Disinfectants |
| D000077324 | Crystalloid Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
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| Topical Foam | Drug | Topical administration |
|
|
| Topical | Other | Topical administration |
|
|
| D012046 |
| Rehabilitation |
| D008919 | Investigative Techniques |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D007552 | Isotonic Solutions |