Back to resultsEvaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery
Primary Purpose
Colorectal Surgery
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic Acid Injection
placebo injection
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Surgery focused on measuring colorectal,blood, transfusion,haemorrhage,tranexamic acid.
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
- NCI, 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
reduction 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).The amount of drained blood will be measured in 1st 24 hours.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03606785
Brief Title
Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery
Official Title
Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Surgery
Keywords
colorectal,blood, transfusion,haemorrhage,tranexamic acid.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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 Injection
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo injection
Intervention Description
patients will receive a placebo of 100 mL 0.9% normal saline
Primary Outcome Measure Information:
Title
reduction 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).The amount of drained blood will be measured in 1st 24 hours.
Time Frame
1 month
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
NCI, Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery
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