Back to resultsSingle Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC
Primary Purpose
Cytoreductive Surgery
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
tranexamic Acid infusion
saline infusion
Sponsored by
About this trial
This is an interventional prevention trial for Cytoreductive Surgery
Eligibility Criteria
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.
Sites / Locations
- National Cancer Institute, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
tranexamic acid group
placebo group
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03646474
Brief Title
Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC
Official Title
Evaluation of the Efficacy & Safety of a Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytoreductive Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tranexamic acid group
Arm Type
Active Comparator
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tranexamic Acid infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
saline infusion
Intervention Description
In the placebogroup, patients will receive a placebo of 100 mL 0.9% normal saline.
Primary Outcome Measure Information:
Title
change in blood loss
Description
Blood loss will be calculated (volume estimated as the blood remaining in sponges and drapes and the volume in suction bottles during surgery).
Time Frame
1st 24 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Cancer Institute, Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC
We'll reach out to this number within 24 hrs