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Tranexamic Acid During Excisional Burn Surgery (TRANEX)

Primary Purpose

Burns, Blood Loss, Surgical, Blood Loss

Status
Recruiting
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Tranexamic acid
Placebo
Sponsored by
Maasstad Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Blood loss, Tranexamic Acid, Burn excisional surgery, Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for burn excisional surgery
  • An expected blood loss of ≥250ml based on the estimation by the performing surgeon on the basis of: (1) ≥ 2 % body surface area excision planned (100-200 cc / % total body surface area, (2) operation technique used (some techniques show more blood loss than others), (3) time after burn trauma (i.e. expected healing)
  • ≥18 year
  • informed consent of patient or legal representative
  • Patients or legal representative should have enough knowledge of Dutch to provide informed consent

Exclusion Criteria:

  • Patients with a recorded coagulopathy in their history
  • The use of anticoagulants (except acetylsalicylic acid or (intensive) prophylaxis low molecular weight heparin >12 hours before surgery)
  • Severe kidney failure (creatinine >500 μmol/L)
  • Allergy for tranexamic acid
  • Diagnosis of acute venous-/arterial thrombosis within 3 months before inclusion
  • Diffuse intravascular coagulation (based on the diffuse intranasal coagulation-score >5)
  • Pregnancy
  • Active breastfeeding
  • History of epilepsy

Sites / Locations

  • Red Cross Hospital
  • Maasstad HospitalRecruiting
  • Martini Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic acid arm

Placebo arm

Arm Description

Tranexamic acid 1500 mg dissolved in 100 ml sodium chloride, once, directly after anesthetizing the participant. In participants with renal insufficiency (creatinine >120 umol/L) the dose will be reduced to 1000 mg.

100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.

Outcomes

Primary Outcome Measures

Blood loss
Volume of blood loss measured during surgery.

Secondary Outcome Measures

Hospital Mortality
% of mortality in patients participating in this study.
Length of stay in days
Number of days admitted after burn trauma.
Graft failure in % of total graft
% of graft failure of the total graft.
Cardiopulmonary complications
i.e. pulmonary embolism, arterial embolism.
Neurologic complications
i.e. stroke of epilepsy
The need for escape medication
Out of protocol administration of tranexamic acid based on massive blood loss.
Extend of fibrinolysis during burn excisional surgery
Measured by ROTEM analysis
Strength of blood clot
Analysis will be performed using (electron) microscope to investigate: strength, thickness, structure of fibrin, fibrin clot networks and cell disposition within the blood clot.
Transfusion requirements
Number of transfusions in the perioperative phase.

Full Information

First Posted
August 16, 2022
Last Updated
August 18, 2022
Sponsor
Maasstad Hospital
Collaborators
Association of Dutch Burn Centres, Martini Hospital Groningen, Red Cross Hospital Beverwijk
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1. Study Identification

Unique Protocol Identification Number
NCT05507983
Brief Title
Tranexamic Acid During Excisional Burn Surgery
Acronym
TRANEX
Official Title
Tranexamic Acid During Excisional Burn Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maasstad Hospital
Collaborators
Association of Dutch Burn Centres, Martini Hospital Groningen, Red Cross Hospital Beverwijk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to access the efficacy of the drug tranexamic acid in reducing blood loss during burn excision surgery.
Detailed Description
This study is a double-blinded, randomized placebo-controlled trial. After informed consent patients will be randomized in either the placebo or the tranexamic acid group (1500 mg). The intervention will be conducted during burn excisional surgery. First, the participant with be anesthetized, whereafter the study medication is administered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Blood Loss, Surgical, Blood Loss, Tranexamic Acid, Burn Excisional Surgery
Keywords
Blood loss, Tranexamic Acid, Burn excisional surgery, Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid arm
Arm Type
Experimental
Arm Description
Tranexamic acid 1500 mg dissolved in 100 ml sodium chloride, once, directly after anesthetizing the participant. In participants with renal insufficiency (creatinine >120 umol/L) the dose will be reduced to 1000 mg.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Tranexamic acid 1500 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, sodium chloride 0.9%
Primary Outcome Measure Information:
Title
Blood loss
Description
Volume of blood loss measured during surgery.
Time Frame
During burn excisional surgery
Secondary Outcome Measure Information:
Title
Hospital Mortality
Description
% of mortality in patients participating in this study.
Time Frame
During total admittance of the patient
Title
Length of stay in days
Description
Number of days admitted after burn trauma.
Time Frame
The length of stay will be evaluated after 3 months after inclusion. If, after 3 months, the patient is still admitted, the status of hospitalisation will be check after an addition 3 months.
Title
Graft failure in % of total graft
Description
% of graft failure of the total graft.
Time Frame
During burn excisional surgery
Title
Cardiopulmonary complications
Description
i.e. pulmonary embolism, arterial embolism.
Time Frame
Within the first 30 days after burn excisional surgery
Title
Neurologic complications
Description
i.e. stroke of epilepsy
Time Frame
Within the first 30 days after burn excisional surgery
Title
The need for escape medication
Description
Out of protocol administration of tranexamic acid based on massive blood loss.
Time Frame
During burn excisional surgery
Title
Extend of fibrinolysis during burn excisional surgery
Description
Measured by ROTEM analysis
Time Frame
During burn excisional surgery
Title
Strength of blood clot
Description
Analysis will be performed using (electron) microscope to investigate: strength, thickness, structure of fibrin, fibrin clot networks and cell disposition within the blood clot.
Time Frame
During burn excisional surgery
Title
Transfusion requirements
Description
Number of transfusions in the perioperative phase.
Time Frame
Perioperative, within the first day after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for burn excisional surgery An expected blood loss of ≥250ml based on the estimation by the performing surgeon on the basis of: (1) ≥ 2 % body surface area excision planned (100-200 cc / % total body surface area, (2) operation technique used (some techniques show more blood loss than others), (3) time after burn trauma (i.e. expected healing) ≥18 year informed consent of patient or legal representative Patients or legal representative should have enough knowledge of Dutch to provide informed consent Exclusion Criteria: Patients with a recorded coagulopathy in their history The use of anticoagulants (except acetylsalicylic acid or (intensive) prophylaxis low molecular weight heparin >12 hours before surgery) Severe kidney failure (creatinine >500 μmol/L) Allergy for tranexamic acid Diagnosis of acute venous-/arterial thrombosis within 3 months before inclusion Diffuse intravascular coagulation (based on the diffuse intranasal coagulation-score >5) Pregnancy Active breastfeeding History of epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
C.H. van der Vlies, MD, PhD
Phone
010 - 2911911
Email
vliesc@maasstadziekenhuis.nl
Facility Information:
Facility Name
Red Cross Hospital
City
Beverwijk
State/Province
Noord-Holland
ZIP/Postal Code
1940 EB
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. de Vries, MD, PhD
Phone
0251-265555
Email
adevries@rkz.nl
Facility Name
Maasstad Hospital
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3079 DZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C.H. van der Vlies
Phone
010-2911911
Email
vliesc@maasstadziekenhuis.nl
Facility Name
Martini Hospital
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S.M.H.J. Scholten-Jaegers
Phone
050 - 524 52 45
Email
s.scholten@mzh.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Tranexamic Acid During Excisional Burn Surgery

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