Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Hemorrhage

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Coagulants

Anesthetics

Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision

Tranexamic Acid Injection

patients will receive a placebo of 100 mL 0.9% normal saline

placebo injection

A total of 46 patients scheduled for explorative laparotomy with the aim of radical debulking surgery for colorectal cancer will be randomized into two equal groups one will receive tranexamic acid and one placebo.

The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. In the control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.

Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery

Blood loss will be calculated (volume estimated as the blood remaining in sponges and drapes and the volume in suction bottles during surgery).The amount of drained blood will be measured in 1st 24 hours.

Assiut University

Assisstant professor of Anesthesia ICU and pain Relief

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Osteosarcoma

Sarcoma

Sarcoma, Ewing

Bone Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

Pharmaceutical Solutions

Fibrinolytic Agents

Amino Acids

Plasminogen

Tissue Plasminogen Activator

Fibrinolysin

Lysine

Loading dose: Prior to surgical incision, and according to allocated arm, pharmacist will prepare TXA injection at a dose of 10mg/kg diluted in 50ml normal saline (maximum concentration 100mg/ml).

Maintenance dose: Throughout surgery, continuous infusion at a dose of 5mg/kg/hour will be given until wound closure.

Loading dose: Prior to surgical incision, and according to allocated arm, pharmacist will prepare 50 ml of 0.9% saline or TXA at a dose of 10mg/kg diluted in 50ml normal saline (maximum concentration 100mg/ml).

Maintenance dose: Throughout surgery, continuous infusion of saline will be given until wound closure.

. TXA, a lysine analogue, reversibly binds to the plasminogen lysine receptors and thereby blocks plasminogen from binding to fibrin (tPA can only activate fibrin-bound plasminogen and produce plasmin responsible for cleaving fibrin molecule and dissolving the blood clot)

Tranexamic acid injection

mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl

Saline

Ahmed M ELGHONEIMY, MD

The purpose of this trial is to investigate whether previously reported benefit of Tranexamic acid in pediatric orthopedic surgeries could be recapitulated in bone tumor surgeries or not through a double blinded randomized controlled trial done in children cancer hospital 57357.

Resection of bone tumors is commonly associated with considerable intra and post-operative blood loss due to extensive soft tissue dissection, multiple bone osteotomies, prolonged operative time. The intraoperative use of limb tourniquet to reduce bleeding may not be applicable in all situations e.g. arm, thigh and pelvic surgeries. The use of cell savers for auto transplantation of blood is not preferred in cancer surgeries. Antifibrinolytic drug are currently used to reduce perioperative blood loss in a variety of orthopedic surgeries. Currently, the most common agents used are EACA and TXA. A third agent, aprotinin, was withdrawn from the market in 2007 owing to safety concerns noted in several studies, suggesting an increased risk of death and renal dysfunction in patients undergoing cardiac surgery. Slow to adopt in obstetric population, TXA became popular for patients with hereditary bleeding disorders for whom menorrhagia, frequent spontaneous nose bleeds, or dental procedures could be life threatening. With strong record as an effective and safe medicine, TXA has earned its place on the World Health Organization List of Essential Medicines as an important drug needed in every health system. More recently, its use has expanded to treat or prevent excessive blood loss from trauma and major surgery, including cardiac, orthopedic, and hepatic procedures. TXA, a lysine analogue, reversibly binds to the plasminogen lysine receptors and thereby blocks plasminogen from binding to fibrin (tPA can only activate fibrin-bound plasminogen and produce plasmin responsible for cleaving fibrin molecule and dissolving the blood clot) TXA has been extensively studied in joint replacement surgeries specifically total knee replacement, scoliosis surgery, and in trauma surgeries. The question of efficacy of TXA in these surgeries was addressed in multiple prospective randomized studies and subsequent meta-analysis. Main concern regarding increased risk of DVT was negated in several of these studies. The American Academy of Orthopedic Surgeons provides a strong recommendation for the use of any administration of TXA for joint arthroplasty and states that it does not seem to increase the risk of thromboembolic or myocardial complications. Junlong Zhong et al. in 2019 published a systematic review and meta-analyses on 2500 pediatric patients undergoing corrective surgery for idiopathic scoliosis. They concluded that TXA was effective in reducing surgical time, intraoperative blood loss and blood transfusion without increasing complications. Levack et al. Published in 2020 a randomized controlled trial on role of TXA in reducing blood loss and transfusion in pediatric patients undergoing a periacetabular osteotomy. They concluded that TXA reduced blood loss by 293ml and reduced frequency of allogenic transfusions by 73%.

The purpose of this trial is to investigate whether previously reported benefit of Tranexamic acid in pediatric orthopedic surgeries could be recapitulated in bone tumor surgeries or not through a double blinded randomized controlled trial done in children cancer hospital 57357.

A prospective, randomized, double-blinded clinical trial will be done on all included case. They will be divided into two groups based randomly using Block Stratified Randomized Software program, after obtaining informed consent from eligible patient or his caregiver into two Arms:

Arm A: patient is not receiving TXA but instead receiving a placebo (saline injection) Arm B: patient is receiving TXA which is colorless solution.

The PI, primary surgeon, anesthesiologist, patient, all assisting surgeons and anesthesiologist as well operating and circulating nurse will be blinded to the study arm to which patient belongs to. Only clinical trial unit and pharmacist will be unblinded.

Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Will Change in Blood Loss and Transfusion Requirements.

Does Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Reduce Blood Loss and Transfusion Requirements? A Double-blinded Randomized Controlled Trial

will be calculated based on measurement of number and weights of blood-soaked surgical swabs. As well as measurement of total volume of blood collected in suction container, after subtracting volume of saline used for washing wound.

Calculation of blood volume to be transfused (no of units in mls) = (Estimated blood volume ×(target HCT -actual HCT))/HCT of one unit of packed RBCs

Children's Cancer Hospital Egypt 57357

Blood Loss, Surgical

Postoperative Hemorrhage

Intraoperative Complications

Postoperative Complications

will injection 10 ml of normal saline to ensure binding

will inject tranexamic acid according to body weight

will inject tranexamic acid in limb salvage surgery of sarcoma patient to check its efficacy in preventing blood loss

normal saline will be injected to ensure placebo

normal saline

muhammad bilal shafiq, fcps

ilyas rafi, frcs

investigator will see the efficacy of tranexamic acid in limb salvage surgery patients which will prevent blood loss and help in conservation of blood products.

Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient

Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss and Associated Complications in Bone Sarcoma Patients Treated With Limb Salvage Surgery: A Randomized Controlled Trial

will start recruiting patient of bone sarcoma in two groups having double blinded \& tranexamic acid efficacy will be checked

Total days of hospital admission 2 months after surgery

to measure blood collected in drain bottle

look for limb swelling for deep vein thrombosis and chest symptoms for any embolic event confirmed by CT chest

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Wounds and Injuries

Fractures, Bone

Neoplasm Metastasis

Fractures, Spontaneous

Neoplastic Processes

Tranexamic acid was administered to the participants at a dose of 1.0 g during the induction of anaesthesia and immediately after the operation.

Tranexamic acid were not administred to the participants .

Tranexamic acid were administered at a dose of 1.0 g during the induction of anaesthesia and immediately after surgery.

This study assesses the safety and efficacy of TXA for patients treated for pathological femur fractures using modular prosthetics.

Tranexamic acid is an efficacious medication for curtailing blood loss, haemoglobin drop, and the requirement for transfusions. Additionally, it is a secure medication, even when administered to oncology patients receiving reduction haemarthroplasty for pathological femoral fractures.

Tranexamic Acid After Pathological Fracture Treated With Modular Arthroplasty

Tranexamic Acid After Pathological Fracture Treated With Modular Arthroplasty: Retrospective Observational Study

The datasets used and/or analysed during the current study are available from the corresponding investigator on reasonable request.

Gross total blood loss was estimated utilizing the formula PBV × (Hctpre- Hctpost)/Hcta

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery	NCT03606785	Colorectal Surg...	Tranexamic Acid... placebo injecti...	18 Years - 65 Years	Assiut University
Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery	NCT03606785	Colorectal Surg...	Tranexamic Acid... placebo injecti...	18 Years - 65 Years	Assiut University
Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Will Change in Blood Loss and Transfusion Requirements.	NCT05024253	Ewing Sarcoma o... Osteosarcoma	Tranexamic acid... Saline	4 Years - 18 Years	Children's Cancer Hospital Egypt 57357
Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient	NCT05427513	Blood Loss, Sur...	Tranexamic acid... normal saline	-	Shaukat Khanum Memorial Cancer Hospital & Research Centre
Tranexamic Acid After Pathological Fracture Treated With Modular Arthroplasty	NCT06244498	Metastases to B...	Tranexamic acid...	-	Podkarpackie Oncological Center

Spots Global Cancer Trial Database for tranexamic acid injection