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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery
• Intervention / Treatment: Drug: Tranexamic Acid Injection; Drug: placebo injection

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • NCI, Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group	Drug: placebo injection; patients will receive a placebo of 100 mL 0.9% normal saline
Active Comparator: tranexamic acid group	Drug: Tranexamic Acid Injection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: July 14, 2018
• First Submitted That Met QC Criteria: July 28, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 4, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: colorectal,blood, transfusion,haemorrhage,tranexamic acid.
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 201617010.2P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No