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Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC

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ClinicalTrials.gov Identifier: NCT03646474
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed H Othman, Assiut University

Brief Summary:
The Tranexamic Acid 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.

Condition or disease Intervention/treatment Phase
Cytoreductive Surgery Drug: tranexamic Acid infusion Drug: saline infusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Evaluation of the Efficacy & Safety of a Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: tranexamic acid group Drug: tranexamic Acid infusion
The tranexamic Acid 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 Comparator: placebo group Drug: saline infusion
In the placebogroup, patients will receive a placebo of 100 mL 0.9% normal saline.




Primary Outcome Measures :
  1. change in blood loss [ Time Frame: 1st 24 hours. ]
    Blood loss will be calculated (volume estimated as the blood remaining in sponges and drapes and the volume in suction bottles during surgery).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646474


Contacts
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Contact: Ahmed Othman 00201005098394 ahmadhothman@gmail.com

Locations
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Egypt
National Cancer Institute, Cairo University Recruiting
Cairo, Egypt
Contact: Ekramy Mansour, MD    00201224642810    ekrameymansoure@yahoo.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Ahmed H Othman, Assisstant professor of Anesthesia ICU and pain Relief, Assiut University
ClinicalTrials.gov Identifier: NCT03646474     History of Changes
Other Study ID Numbers: 201617027.2p
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants