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

NCT03606785 | Completed Phase 4

• 1 other identifier: 201617010.2P
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Surgery

Keywords

colorectal,blood, transfusion,haemorrhage,tranexamic acid.

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

tranexamic acid group

ACTIVE COMPARATOR

Drug: Tranexamic Acid Injection

placebo group

PLACEBO COMPARATOR

Drug: placebo injection

Interventions

Tranexamic Acid Injection DRUG

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

tranexamic acid group

placebo injection DRUG

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

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1 and ASA 2 patients scheduled for colorectal cancer surgery.
• Age above 18 years \& less than 65 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

NCI, Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor of Anesthesia ICU and pain Relief

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: July 31, 2018
• Study Start: August 5, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

EG (1)