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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03646474
Other study ID # 201617027.2p
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2018
Est. completion date January 31, 2020

Study information

Verified date June 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
tranexamic Acid infusion
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.
saline infusion
In the placebogroup, patients will receive a placebo of 100 mL 0.9% normal saline.

Locations

Country Name City State
Egypt National Cancer Institute, Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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.
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