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

A

Assiut University

Status and phase

Completed
Phase 4

Conditions

Colorectal Surgery

Treatments

Drug: Tranexamic Acid Injection
Drug: placebo injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03606785
201617010.2P

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups, including a placebo group

tranexamic acid group
Active Comparator group
Treatment:
Drug: Tranexamic Acid Injection
placebo group
Placebo Comparator group
Treatment:
Drug: placebo injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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