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Trial record 80 of 199 for:    Protamine

DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION)

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ClinicalTrials.gov Identifier: NCT03954314
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Brief Summary:
The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.

Condition or disease Intervention/treatment Phase
Bleeding Surgical Blood Loss Seizures Drug: Tranexamic Acid Phase 4

Detailed Description:
Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. It results from the blood thinners that are needed for use. Intravenous tranexamic acid (TxA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TxA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TxA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TxA is used directly on the tissues (topically) for other type of surgeries (joints), TxA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TxA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The pharmacy will prepare 2 syringes of 50 ml of topical TxA (5 g) or placebo. They will also prepare for the same patient 2 syringes of 50 ml (5 g) for intravenous (i.v.) injection or placebo. TxA is similar in all aspects to normal saline. Blinding of both teams will be easy. The syringes will be prepared and randomized in pharmacy before the surgery.
Primary Purpose: Prevention
Official Title: Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION) Study
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Topical Tranexamic Acid/Placebo
Topical Tranexamic Acid 5g to 10g (50 to 100mL) or placebo. The topical will be poured into the pericardial and mediastinal cavities after protamine administration.
Drug: Tranexamic Acid
Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.
Other Name: Cyklokapron

Active Comparator: Intravenous Tranexamic Acid/Placebo
Intravenous Tranexamic Acid 1 to 10g (10 to 100mL) or placebo administered intravenously at the induction of anesthesia as a bolus-infusion.
Drug: Tranexamic Acid
Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.
Other Name: Cyklokapron




Primary Outcome Measures :
  1. The composite of patients receiving in-hospital red blood cell transfusions or experiencing a seizure [ Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) ]
    To determine in patients undergoing on-pump cardiac surgery, if topical tranexamic acid (intra-pericardial) is superior to the usual intravenous tranexamic acid administration for reducing the risk of in-hospital red blood cell transfusion or seizure (composite).


Secondary Outcome Measures :
  1. The proportion of patients in-hospital who receive red blood cell transfusions [ Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) ]
    To determine whether topical tranexamic acid (intra-pericardial) compared with intravenous tranexamic acid administration reduces the risk of in-hospital red blood cell transfusion.

  2. The proportion of patients in-hospital who experience a seizure [ Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) ]
    To determine whether topical tranexamic acid (intra-pericardial) compared with intravenous tranexamic acid administration reduces the risk of in-hospital seizure. The proportion of patients who experience a seizure will be analyzed using Fisher's exact test.


Other Outcome Measures:
  1. Blood product transfusions [ Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) ]
    Analyzed using an ANCOVA model. In such a model, bags of blood product will be included as a dependent variable, whereas dose of tranexamic acid and treatment will be included as covariates.

  2. Re-operation for bleeding or tamponade [ Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) ]
    Analyzed with a binomial regression

  3. Length of ICU stay [ Time Frame: Number of hours in ICU are being collected at the Post-Operative Visit. Hour collection will start upon arrival at ICU post surgery and stop at ICU exit, up to 10 days maximum. ]
    Analyzed using an ANCOVA model.

  4. MACE (Death, non-fatal Myocardial Infarction (MI), or non-fatal stroke) [ Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) ]
    A Cox proportional hazard model will be used to analyze the time to the first occurrence of the composite of death, non-fatal MI, or non-fatal stroke (MACE).



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

Inclusion Criteria:

  1. ≥ 18 years of age
  2. Undergoing a cardiac surgical procedure (i.e. isolated coronary artery bypass graft (CABG), isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass (CPB) and median sternotomy
  3. Provide written informed consent

Exclusion Criteria:

  1. Allergy to tranexamic acid
  2. Undergoing minimally invasive surgery
  3. Fulfill any of the following transfusion risk factors (A-D):

    A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis

  4. History of previous cardiac surgery
  5. Severe renal impairment (serum creatinine >250 µmol/L)
  6. Pre-operative hemoglobin <120 g/L
  7. Pre-operative thrombocytopenia (<50,000 platelets per µL)
  8. Expected circulatory arrest
  9. Pregnancy or breast feeding
  10. Previously enrolled in the DEPOSITION trial

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): NCT03954314


Contacts
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Contact: Ingrid Copland, CCRA 905-527-4322 ext 40368 cogency@phri.ca
Contact: Austin Browne, PhD 905-527-4322 ext 40582 Austin.Browne@phri.ca

Sponsors and Collaborators
Population Health Research Institute
Investigators
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Principal Investigator: Andre Lamy, MD Population Health Research Institute

Publications of Results:

Other Publications:
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03954314     History of Changes
Other Study ID Numbers: DEPOSITION
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Population Health Research Institute:
Tranexamic Acid
On-pump Cardiac Surgery
Additional relevant MeSH terms:
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Seizures
Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Intraoperative Complications
Postoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants