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Transfusion Strategies for Pediatric Liver Transplantation

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ClinicalTrials.gov Identifier: NCT02951013
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief Summary:

The patients assigned to the restrictive group will receive transfusion once the hemoglobin concentration falls below 6.0 g per deciliter, with a target hemoglobin range of 7.5 to 8.0 g per deciliter. Patients assigned to the liberal group will receive transfusion once the hemoglobin concentration falls below 8.0 g per deciliter, with a target hemoglobin range of 9.5 to 10.0 g per deciliter.

The primary outcomes: Death from all causes in six months after randomization. Incidence of perioperative complications, including sepsis , pulmonary complications, portal vein thrombosis, hepatic artery thrombosis and transfusion-related adverse events.

Secondary outcomes: Intraoperative blood transfusion amount, postoperative blood transfusion amount, postoperative inflammatory reaction, mechanical ventilation time in the intensive care unit, lengths of stay in the intensive care unit and the hospital,and hospitalization expenses.


Condition or disease Intervention/treatment Phase
Pediatric Patients Who Need Liver Transplantation Other: restrictive transfusion Other: liberal transfusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Perioperative Liberal or Restrictive Transfusion in Pediatric Liver Transplantation: A Prospective Randomized Controlled Trial
Actual Study Start Date : December 7, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: restrictive group
Patients in this group will have a transfusion when the hemoglobin concentration falls below 6g/dL, with a target hemoglobin range of 7.5-8.0g/dL.
Other: restrictive transfusion
Transfusion will start when the hemoglobin concentration falls below 6.0 g/dL

Active Comparator: liberal group
Patients in this group will have a transfusion when the hemoglobin concentration falls below 8g/dL, with a target hemoglobin range of 9.5-10.0g/dL.
Other: liberal transfusion
Other Name: Transfusion will start when the hemoglobin concentration falls below 8.0 g/dL




Primary Outcome Measures :
  1. Mortality [ Time Frame: up to 6 months after randomization ]
  2. Proportion of patients who have Perioperative complications [ Time Frame: up to 6 months after randomization ]

Secondary Outcome Measures :
  1. Amount of intraoperative blood transfusion [ Time Frame: during surgery ]
  2. Amount of blood transfusion during perioperative period [ Time Frame: up to 7 days after surgery ]
  3. Heart rate during surgery [ Time Frame: during surgery ]
  4. Blood pressure during surgery [ Time Frame: during surgery ]
  5. Arterial partial pressure of oxygen during surgery [ Time Frame: during surgery ]
  6. Plasma lactic acid concentration during surgery [ Time Frame: during surgery ]
  7. Oxygen uptake rate during surgery [ Time Frame: during surgery ]
  8. Daily score on Pediatric end-stage liver disease (PELD) assessment [ Time Frame: up to 7 days after randomization ]
  9. Length of Mechanical Ventilation in the intensive care unit [ Time Frame: at discharge/up to 30 days after randomization ]
  10. Lengths of stay in the intensive care unit [ Time Frame: at discharge/up to 30 days after randomization ]
  11. Proportion of patients who need a second hepatic surgery [ Time Frame: up to 7 days after randomization ]
  12. Hospitalization Days [ Time Frame: up to 30 days after randomization ]
  13. Out of pocket expenditure for hospitalization [ Time Frame: at discharge/up to 30 days after randomization ]


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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The investigators study included pediatric patients (6 months< the moon's age <36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.

Exclusion Criteria:

  • The exclusion criteria of the study were a congenital sufferer from heart, lung, kidney, nervous system or blood disease,active Lung infection, a history of liver transplantation, Multivisceral transplantation, refused to participate the study.

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): NCT02951013


Contacts
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Contact: Jie Tian 862168383702 vaseline2001@hotmail.com

Locations
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China, Shanghai
Renji Hospital affliated to Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200126
Contact: JIE TIAN, Ph.D    862168383702    vaseline2001@hotmail.com   
Sponsors and Collaborators
RenJi Hospital

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02951013     History of Changes
Other Study ID Numbers: PLT20161023
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided