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

Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606785
• Other study ID #: 201617010.2P
• Status: Completed
• Phase: Phase 4
• Start date: August 5, 2018
• Est. completion date: January 31, 2020

Study information

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

Clinical Trial 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.

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Surgery

Intervention

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
• placebo injection
patients will receive a placebo of 100 mL 0.9% normal saline

Locations

Country	Name	City	State
Egypt	NCI, 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	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