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Trial record 45 of 419 for:    TRANEXAMIC ACID

Evaluation of the Safety and Efficacy of the Second Dose of Tranexamic Acid

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ClinicalTrials.gov Identifier: NCT03846973
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Ayman El-Menyar, Hamad Medical Corporation

Brief Summary:

TXA is currently administered pre-hospital in Canada, Germany, United Kingdom and Israel . These studies demonstrated that TXA use did not result in any detectable complications or adverse events. It is considered an ideal pre-hospital treatment because: (a) patients with severe hemorrhage die early more often than patients without hemorrhage; (b) it seems that the earlier treatment is administered, the better; (c) it is stable and easily stored; and (d) it is easily administered by paramedics. Herein, the study aimed to evaluate the effect of administration of second dose of Tranexamic acid infusion in the hospital setting in comparison to not receiving the second dose on the outcomes of trauma patients with an evidence of significant hemorrhage.

Recently, HGH ambulance service has included pre-hospital administration of TXA in trauma patients with significant hemorrhage. So, all eligible trauma patients will receive pre-hospital TXA (first dose) slowly over 10 minutes by the critical care paramedics as standard of care.

Inclusion Criteria: All adult trauma male and female patients (≥18 or <90 years) with evidence of significant hemorrhage (systolic blood pressure <90 mmHg or heart rate >110 beats per minutes, or both) or had Capillary Refill Time 3-4 seconds and received first dose of prehospital TXA will be included in the study.

Exclusion criteria:

  1. Age > 90 or < 18 years of age
  2. Inability to obtain intravenous access (intraosseous access not sufficient)
  3. Documented cervical cord injury with motor deficit
  4. Known prisoner
  5. Known pregnancy
  6. Traumatic arrest with > 5 minutes CPR without return of vital signs
  7. Penetrating cranial injury
  8. Traumatic brain injury with brain matter exposed
  9. Isolated drowning or hanging victims
  10. Wearing an opt out bracelet. Patient data will include demographics, time since injury, type of injury (blunt or penetrating), Glasgow Coma Score(GCS), Injury severity score (ISS), systolic blood pressure, respiratory rate, central capillary refill time, estimated number of hours since injury, laboratory findings, blood transfusion, units of transfused blood, management, complications and outcome.

The primary outcome will be death in hospital within 4 weeks of injury. Secondary outcomes will be morbidity (thromboembolic events, sepsis, Acute respiratory distress syndrome and organ failure), and number of blood transfusions (Massive transfusion protocol) and hospital length of stay.


Condition or disease Intervention/treatment Phase
Tranexamic Acid Drug: Tranexamic Acid Other: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of the Second Dose of Tranexamic Acid Administration of Trauma Patients: A Randomized, Double-blind Controlled Clinical Trial
Actual Study Start Date : December 2, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic acid
group-I will include 110 patients with initial pre-hospital TXA administered slowly over 10 minutes followed by an intravenous infusion of 1 g TXA to be given and completed over 8 h in the hospital
Drug: Tranexamic Acid
intravenous infusion of 1 g infusion to be given and completed over 8 h in the hospital
Other Name: TXA

Placebo Comparator: Placebo
group-II will include 110 patients with initial pre-hospital TXA administered slowly over 10 minutes but will receive placebo (normal saline) infusion to be given and completed over 8 h in the hospital
Other: Placebo
placebo (normal saline) infusion to be given and completed over 8 h in the hospital
Other Name: normal saline




Primary Outcome Measures :
  1. mortality [ Time Frame: 4 weeks ]
    Number of participants who died from each study arm


Secondary Outcome Measures :
  1. morbidity [ Time Frame: 4 weeks post injury ]
    Number of participants of each study arm who developed thromboembolic events, sepsis, Acute respiratory distress syndrome and organ failure)

  2. number of blood transfusions [ Time Frame: 4 weeks post injury ]
    umber of participants of each study arm who received blood transfusions (MTP: massive transfusion protocol)

  3. Hospital length of stay [ Time Frame: 4 weeks post injury ]
    Number of hospital length of stay for each study group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All adult trauma male and female patients (≥18 or <90 years) with evidence of significant hemorrhage (systolic blood pressure <90 mmHg or heart rate >110 beats per minutes, or both) or had Capillary Refill Time 3-4 seconds [2] and received first dose of prehospital TXA will be included in the study.

Exclusion Criteria:

  1. Age > 90 or < 18 years of age
  2. Inability to obtain intravenous access (intraosseous access not sufficient)
  3. Documented cervical cord injury with motor deficit
  4. Known prisoner
  5. Known pregnancy
  6. Traumatic arrest with > 5 minutes CPR without return of vital signs
  7. Penetrating cranial injury
  8. Traumatic brain injury with brain matter exposed
  9. Isolated drowning or hanging victims
  10. Wearing an opt out bracelet.

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): NCT03846973


Contacts
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Contact: Ayman El-Menyar, MD +974-44394029 elmenyar@yahoo.com
Contact: Mohammad Asim asim.jmi@gmail.com

Locations
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Qatar
Hamad General Hospital Recruiting
Doha, Qatar
Contact: Ayman El-Menyar, MD         
Sponsors and Collaborators
Hamad Medical Corporation

Publications:
World Health Organization. Violence, Injuries, and Disability: Biennial 2008-2009 Report. Geneva, Switzerland: WHO; 2010.
Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study) (PATCH). Ongoing Clinical Trials. Retrieved from https://clinicaltrials.gov/ct2/show/NCT02187120 accessed on May 20, 2016
Electronics Medicines Compendium (2011) Cyklopron Standard Product Characteristics. http://www.medicines.org.uk/EMC/medicine/1489/SPC/Cyklokapron+Injection/ [Accessed 23rd May 2016].
World Health Organisation (2011) Model Lists of Essential Medicines. 17th Ed. http://www.who.int/medicines/publications/essentialmedicines/en/ Accessed 23rd May 2016].

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Responsible Party: Dr. Ayman El-Menyar, Director, Trauma & Vascular Research, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03846973     History of Changes
Other Study ID Numbers: 16417/16
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only the lead PI will have the access to the data which will be coded with subject identifier to ensure data safety and confidentiality.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dr. Ayman El-Menyar, Hamad Medical Corporation:
Trauma, Mortality, Tranexamic , Prehospital
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants