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Trial record 40 of 721 for:    Recruiting, Not yet recruiting, Available Studies | "Arrhythmias, Cardiac"

Platelet Transfusion During Neonatal Open Heart Surgery (CPB)

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ClinicalTrials.gov Identifier: NCT03045068
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Nischal Krishamurthy Gautam, The University of Texas Health Science Center, Houston

Brief Summary:

Hypothesis:

Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood products after cardiac surgery.

Background:

What is the Problem? - Bleeding, Transfusion and Outcomes

  1. Excessive bleeding after neonatal cardiac surgery has been independently associated with increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal open-heart surgery has multiple etiologies such as immaturity of the building blocks of coagulation, effects of deep hypothermia, longer CPB times, altered flow states and dilutional state induced by being on CPB leading to low platelet count, low platelet function, low fibrinogen levels, altered fibrinogen polymerization, complement activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass in children was deemed to be the CPB circuit volume and the effect of hemodilution.4
  2. The dilutional coagulopathy after neonatal CPB requires intense damage control resuscitation with massive transfusion of platelets, packed red blood cells (PRBC), cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in neonates undergoing open-heart surgery there was a significant drop in platelet counts after bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated with this drop , the average intraoperative transfusion load in neonates undergoing cardiac surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51± 21 ml/kg, cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10 ml/kg. In addition 72% of these patients were exposed to a 3-factor prothrombin complex concentrate (Bebulin®). Although this "throw the kitchen sink" approach is effective in achieving hemostasis, it comes with significant effects on post CPB hemodynamics, constantly changing hematocrit, variable blood volume with inability to achieve steady state inotropic state affecting cardiac output, oxygen delivery and adding to pulmonary hypertension.

Overall, having higher platelet counts at the time of weaning from cardiopulmonary bypass has distinct advantages of reducing transfusions and improving outcomes.


Condition or disease Intervention/treatment Phase
Cardiac Disease Cardiac Surgery Cardiopulmonary Bypass Platelet Transfusion Arrythmia, Cardiac Mortality Biological: Platelet Transfusion Biological: FFP and Cryoprecipitate Biological: PRBC and cell saver Transfusion Biological: Factor Concentrate (Bebulin) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomized trial in neonates comparing platelet apheresis transfusion prior to termination of CPB versus standard transfusion of platelet apheresis after modified ultrafiltration and protamine administration
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Platelet Transfusion During Neonatal Open Heart Surgery
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group

Platelet Transfusion Management

  1. Pre-Termination of CPB- Platelet Transfusion 10ml/kg to be administered to the patient via central venous access when the patient has been rewarmed to 35*C, (the Sano or BT shunt clip is still on in children with SV physiology)
  2. Post CPB- Platelet transfusion 10ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.
Biological: Platelet Transfusion

Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.

  1. Initial transfusion to occur proximal to the hemofilter on the MUF circuit for as long as MUF lasts
  2. Subsequent platelet transfusion continued till completion via central venous access to the patient
Other Name: Platelet

Biological: FFP and Cryoprecipitate
  1. 1 unit of cryoprecipitate administered during MUF and or after MUF as needed
  2. FFP transfusion 10ml/kg during MUF and or after MUF as needed
Other Name: FFP

Biological: PRBC and cell saver Transfusion
1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology
Other Name: PRBC

Biological: Factor Concentrate (Bebulin)
1. Based on clinical bleeding and achievement of hemostasis
Other Name: Bebulin

Active Comparator: Control Group

Platelet Transfusion Management

  1. Pre-Termination of CPB- No intervention
  2. Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.
Biological: Platelet Transfusion

Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.

  1. Initial transfusion to occur proximal to the hemofilter on the MUF circuit for as long as MUF lasts
  2. Subsequent platelet transfusion continued till completion via central venous access to the patient
Other Name: Platelet

Biological: FFP and Cryoprecipitate
  1. 1 unit of cryoprecipitate administered during MUF and or after MUF as needed
  2. FFP transfusion 10ml/kg during MUF and or after MUF as needed
Other Name: FFP

Biological: PRBC and cell saver Transfusion
1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology
Other Name: PRBC

Biological: Factor Concentrate (Bebulin)
1. Based on clinical bleeding and achievement of hemostasis
Other Name: Bebulin




Primary Outcome Measures :
  1. Number of Donor Exposures [ Time Frame: 0-72 hours ]
    All Blood products administered (PRBC, FFP, Cryo, Platelets) from termination of CPB to first 24 hours post op


Secondary Outcome Measures :
  1. 4-PCC and Factor 7 [ Time Frame: 0-72 hours ]
    Number of exposures of 4-PCC and Factor 7

  2. CPB to Chest Approximation [ Time Frame: 0-72 hours ]
    Time from termination of CPB to Chest Approximation

  3. Chest tube output [ Time Frame: 0-24 hours ]
    Chest tube output first 24 hours

  4. Inotropic support [ Time Frame: 0-24 hours ]
    Inotropic support at time of chest approximation and at 24 hours postop

  5. mechanical ventilation [ Time Frame: 0-72 hours ]
    Length of mechanical ventilation

  6. Mortality [ Time Frame: 0-30 days ]
    30 day mortality

  7. Perioperative cardiac arrest [ Time Frame: 0-72 hours ]
    Perioperative cardiac arrest first 72 hours

  8. Arrhythmia [ Time Frame: 0-72 hours ]
    Arrhythmia



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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All neonates and infants less than 3 months of age under 4 kilograms undergoing open heart surgery and cardiopulmonary bypass

Exclusion Criteria:

  1. Redo open heart surgery
  2. Bleeding Disorders - such as von Willebrand Disease, Hemophilia

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): NCT03045068


Contacts
Contact: Nischal K Gautam, MD 713-500-6200 Nischal.K.Gautam@uth.tmc.edu
Contact: James A Pierre 713-500-6301 James.A.Pierre@uth.tmc.edu

Locations
United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Ben Benitez    713-704-4440    Etta.Hodge@memorialhermann.org   
Contact: Etta Hodge    713-704-5095    Etta.Hodge@memorialhermann.org   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Nischal K Gautam, MD The University of Texas Health Science at Houston

Responsible Party: Nischal Krishamurthy Gautam, Associate Professor of Anesthesiology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03045068     History of Changes
Other Study ID Numbers: HSC-MS-16-1034
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes