Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic Surgery

NCT04224116 | Completed Phase 4 DMC

• 1 other identifier: TA
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bleeding after thoracic surgery is a major cause of perioperative hemodynamic instability and transfusion requirement, which can lead to a rise of morbidity, mortality and costs. The objective of this study is to evaluate the efficiency of tranexamic acid (TA) in the prevention of perioperative bleeding in thoracic hemorrhagic surgery.

Conditions

Bleeding

Keywords

tranexamic acid; Antifibrinolytic agents; bleeding; blood transfusion; thoracic surgery.

Outcome Measures

Primary Outcomes (1)

• intraoperative bleeding volume

  The blood volume collected in the suction tanks and the operative drapes intraoperatively

  five hours

Secondary Outcomes (2)

• The number of red globular caps transfused for each group

  one month

• bleeding volume in the thoracic drains postoperatively

  one month

Study Arms (2)

Group TA

EXPERIMENTAL

receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.

Drug: Tranexamic acid injection

Group SSI

PLACEBO COMPARATOR

Serum saline isotonic (SSI) group: placebo with isotonic saline serum.

Drug: SSI

Interventions

Tranexamic acid injection DRUG

to receive tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.

Also known as: EXACYL

Group TA

SSI DRUG

Serum Salin isotonic injected

Also known as: placebo

Group SSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux.

You may not qualify if:

• Patients who have had a major complication of surgery other than bleeding requiring revision within 24 hours or a complication related to anesthesia, and cases of non-compliance with the anesthetic protocol are excluded.

Sponsors & Collaborators

• University Tunis El Manar: lead

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Tahar Mestiri, Professor

  university Manar Tunis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind investigation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery

Model Details: It's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified. Two groups of patients: * TA group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act. * Serum saline isotonic (SSI) group: placebo with isotonic saline serum.

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: January 13, 2020
• Study Start: January 1, 2014
• Primary Completion: October 2, 2019
• Study Completion: October 2, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share