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Completed

NCT Number: NCT03606785

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.

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Key information

Conditions

Colorectal Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NCI, Cairo university

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo injection

Drug

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

Primary outcomes

  1. reduction in blood loss

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2018
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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