Cytoreductive Surgery Clinical Trial
Official title:
Evaluation of the Efficacy & Safety of a Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC
Verified date | June 2022 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Tranexamic Acid 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.
Status | Completed |
Enrollment | 46 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion criteria - ASA 1 and ASA 2 patients scheduled for colorectal cancer surgery. - Age above 18 years & less than 65 years. Exclusion criteria: - Thrombophilia or any bleeding disorder. - Previous or active thromboembolic disease. - Family history of thromboembolism. - Known Allergy to TA. - Liver dysfunction. - Preexisting renal dysfunction (serum creatinine >1.2 mg/dL). - Coronary stent insertion within a year prior to operation. - Cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure), - Lifelong warfarin therapy for thromboembolism prophylaxis. |
Country | Name | City | State |
---|---|---|---|
Egypt | National Cancer Institute, Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in blood loss | Blood loss will be calculated (volume estimated as the blood remaining in sponges and drapes and the volume in suction bottles during surgery). | 1st 24 hours. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05063019 -
Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index
|
N/A | |
Recruiting |
NCT05597683 -
Quadratus Lumborum Block After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy
|
N/A | |
Withdrawn |
NCT04125225 -
What Are the Experiences of Patients With Pseudomyxoma Peritonei?
|
||
Withdrawn |
NCT05390021 -
PET/MRI in Endometrial Cancer
|
N/A | |
Completed |
NCT02189434 -
Does Serum Procalcitonin Levels Predict Sepsis in Patients Undergoing Cytoreductive Surgery
|
N/A | |
Not yet recruiting |
NCT05353582 -
Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases
|
Phase 2 | |
Recruiting |
NCT05939193 -
Effect of Urine-guided Hydration on Acute Kidney Injury After CRS-HIPEC
|
N/A | |
Completed |
NCT06398678 -
Anesthesia Management in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
|
||
Not yet recruiting |
NCT05633199 -
Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer
|
N/A | |
Completed |
NCT04981639 -
TAP and IMS for HIPEC
|
Phase 3 | |
Completed |
NCT04744688 -
Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment
|
||
Recruiting |
NCT05942209 -
ECO-LEAK Technique: Early Detection of Colorectal Anastomotic Leakage by Transvaginal Ultrasound
|