Tranexamic Acid Contribution in the Prevention of Periope... | NCT04224116

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

NCT04224116

Sponsor

University Tunis El Manar

Status

Completed

Last Update Posted

Jan 13, 2020Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Bleeding

Interventions

Tranexamic acid injection
SSI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Oct 2, 2019Actual

Completion Date

Oct 2, 2019Actual

First Submitted Date

Oct 1, 2019

First Submission Date that Met QC Criteria

Jan 7, 2020

First Posted Date

Jan 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2020

Last Update Posted Date

Jan 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amani Ben Haj Youssef, Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery, University Tunis El ManarPrincipal Investigator

Lead Sponsor

University Tunis El ManarOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.	Group TA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intraoperative bleeding volume	The blood volume collected in the suction tanks and the operative drapes intraoperatively	five hours

Secondary Outcomes

Measure	Description	Time Frame
The number of red globular caps transfused for each group	transfusion if hemoglobin less than 7 g / dl	one month
bleeding volume in the thoracic drains postoperatively	bleeding volume in the thoracic drains postoperatively every day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tahar Mestiri, Professor	university Manar Tunis	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid

Ancestor Terms

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.