ClinicalTrials.gov
ClinicalTrials.gov Menu

Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03494595
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hamada Hamed, Assiut University

Brief Summary:
The study aims to correlate the perioperative results of a device called thromboelastogram, which is used to detect coagulation abnormalities, with thrombotic complications during pediatric recipient liver transplantation.

Condition or disease Intervention/treatment
Pediatric Liver Transplantation Procedure: Pediatric Liver transplantation

Detailed Description:

Pediatric patients undergoing liver transplant are at risk for significant bleeding and thrombotic complications. Studies in both pediatric and adult cohorts estimate an incidence of thrombotic events in up to 26% of cases. Hepatic artery and portal vein thrombosis (PVT) are reported at rates of 5-15% in pediatric cohorts, which is three to four times the incidence in adults. Bleeding estimates are harder to quantify given variability in the definition of major bleeding, but range from approximately 5 to 9%.The contribution of bleeding to morbidity is difficult to quantify, but thrombotic complications are known to reduce graft survival and contribute significantly to adverse outcomes, with mortality rates approaching 50% in those with hepatic artery thrombosis.

Thromboelastometry offers rapid, comprehensive, and global clinical assessment of the patients' coagulation status, as demonstrated by several studies.

Little data exists in the use of thromboelastography (TEG) in pediatric liver transplantation. In 2011, Curiel et al implemented pre-transplant TEGs for patients listed for liver transplantation. The invistigators sought to examine if there were any correlations with preoperative hypercoagulable indices on the TEG and postoperative thrombotic complications.The invistigators have identified that a preoperative hypercoagulable TEG portends to thrombotic complications in pediatric liver transplant patients. Further studies are needed to explore perioperative management strategies for high risk patients to prevent the development of postoperative thrombotic complications based upon preoperative TEG studies. That's why the invistigators will study the perioperative thromboelastometry as a predictor of thrombotic complications during pediatric recipient liver transplantation.


Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Thrombosis
Patients who will develop thrombosis perioperatively
Procedure: Pediatric Liver transplantation
Pediatric Liver transplantation

No thrombosis
Patients who will not develop thrombosis perioperatively
Procedure: Pediatric Liver transplantation
Pediatric Liver transplantation




Primary Outcome Measures :
  1. Intraoperative thrombotic events (hepatic artery or portal vein thrombosis) [ Time Frame: Intraoperative, an average of 12 hours ]
    Any documented thrombus by imaging or clinical diagnosis made by direct observation during a surgical procedure. This includes both venous and arterial thromboembolic events.

  2. Thrombotic events (hepatic artery or portal vein thrombosis) [ Time Frame: Postoperative up to 1 week. ]
    Patients will be screened for hepatic thrombosis regularly with liver Doppler ultrasound during the first week postoperatively, with confirmatory imaging based on identified clinical or imaging concerns.


Secondary Outcome Measures :
  1. Coagulation Time preoperative. [ Time Frame: Preoperative up to 1 day before surgery. ]
    Coagulation Time (CT, in seconds), the time from the start of measurement until a clot firmness of 2 mm is detected by thromboelastometry preoperatively.

  2. Coagulation Time in pre-anhepatic stage. [ Time Frame: In pre-anhepatic stage, an average of 4 hours. ]
    Coagulation Time (CT, in seconds), the time from the start of measurement until a clot firmness of 2 mm is detected by thromboelastometry during pre-anhepatic stage.

  3. Coagulation Time in anhepatic stage. [ Time Frame: In anhepatic stage, an average of 2 hours. ]
    Coagulation Time (CT, in seconds), the time from the start of measurement until a clot firmness of 2 mm is detected by thromboelastometry during anhepatic stage.

  4. Coagulation Time after reperfusion. [ Time Frame: After reperfusion, an average of 4 hours. ]
    Coagulation Time (CT, in seconds), the time from the start of measurement until a clot firmness of 2 mm is detected by thromboelastometry after reperfusion.

  5. Coagulation Time at the end of surgery. [ Time Frame: At the end of surgery, an average of 12 hours. ]
    Coagulation Time (CT, in seconds), the time from the start of measurement until a clot firmness of 2 mm is detected by thromboelastometry at the end of surgery.

  6. Clot Formation Time preoperative [ Time Frame: Preoperative up to 1 day before surgery. ]
    Clot Formation Time (CFT, in seconds), the time needed to increase clot firmness from 2 to 20 mm amplitude as detected by thromboelastometry preoperatively.

  7. Clot Formation Time in pre-anhepatic stage. [ Time Frame: In pre-anhepatic stage, an average of 4 hours. ]
    Clot Formation Time (CFT, in seconds), the time needed to increase clot firmness from 2 to 20 mm amplitude as detected by thromboelastometry during pre-anhepatic stage.

  8. Clot Formation Time in anhepatic stage. [ Time Frame: In anhepatic stage, an average of 2 hours. ]
    Clot Formation Time (CFT, in seconds), the time needed to increase clot firmness from 2 to 20 mm amplitude as detected by thromboelastometry during anhepatic stage.

  9. Clot Formation Time after reperfusion. [ Time Frame: After reperfusion, an average of 4 hours. ]
    Clot Formation Time (CFT, in seconds), the time needed to increase clot firmness from 2 to 20 mm amplitude as detected by thromboelastometry after reperfusion.

  10. Clot Formation Time at the end of surgery [ Time Frame: At the end of surgery, an average of 12 hours. ]
    Clot Formation Time (CFT, in seconds), the time needed to increase clot firmness from 2 to 20 mm amplitude as detected by thromboelastometry at the end of surgery.

  11. Angle α preoperative. [ Time Frame: Preoperative up to 1 day before surgery. ]
    Angle α, the angle of tangent at 2 mm amplitude (ANG α, in degrees) as detected by thromboelastometry preoperatively.

  12. Angle α in pre-anhepatic stage. [ Time Frame: In pre-anhepatic stage, an average of 4 hours. ]
    Angle α, the angle of tangent at 2 mm amplitude (ANG α, in degrees) as detected by thromboelastometry during pre-anhepatic stage.

  13. Angle α in anhepatic stage. [ Time Frame: In anhepatic stage, an average of 2 hours. ]
    Angle α, the angle of tangent at 2 mm amplitude (ANG α, in degrees) as detected by thromboelastometry during anhepatic stage.

  14. Angle α after reperfusion. [ Time Frame: After reperfusion, an average of 4 hours. ]
    Angle α, the angle of tangent at 2 mm amplitude (ANG α, in degrees) as detected by thromboelastometry after reperfusion.

  15. Angle α at the end of surgery [ Time Frame: At the end of surgery, an average of 12 hours. ]
    Angle α, the angle of tangent at 2 mm amplitude (ANG α, in degrees) as detected by thromboelastometry at the end of surgery.

  16. Maximum Clot Firmness preoperative. [ Time Frame: Preoperative up to 1 day before surgery. ]
    Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography preoperatively.

  17. Maximum Clot Firmness in pre-anhepatic stage. [ Time Frame: In pre-anhepatic stage, an average of 4 hours. ]
    Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography during pre-anhepatic stage.

  18. Maximum Clot Firmness in anhepatic stage. [ Time Frame: In anhepatic stage, an average of 2 hours. ]
    Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography during anhepatic stage.

  19. Maximum Clot Firmness after reperfusion. [ Time Frame: After reperfusion, an average of 4 hours. ]
    Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography after reperfusion.

  20. Maximum Clot Firmness at the end of surgery. [ Time Frame: At the end of surgery, an average of 12 hours. ]
    Maximum Clot Firmness (MCF, in millimeters), the maximum amplitude of clot firmness finally achieved as detected by thromboelastography at the end of surgery.

  21. Warm ischemic time [ Time Frame: during the surgery, an average of 2 hours ]
    in minutes

  22. Length of ICU stay [ Time Frame: after the surgery, an average of 1 month ]
    in days

  23. Length of hospital stay [ Time Frame: postoperative, an average of 1 month ]
    in days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatrics undergoing liver transplantation
Criteria

Inclusion Criteria:

  • Male or female participant must be between 3 months and 15 years of age.
  • Participant is a recipient of a first liver allograft from living donors.
  • Participant is a single-organ recipient (liver only).
  • Participants' parent/guardian is capable of understanding the purposes and risks of the study and must sign an informed consent for the study.

Exclusion Criteria:

  • Pre-existing blood disease.
  • A history of liver transplantation.
  • Multivisceral transplantation.
  • Participants' parent/guardian refused to participate in 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): NCT03494595


Contacts
Contact: Ahmed HH Amin 1060431973 ext +20 ahmed.hamada777@gmail.com

Locations
Egypt
Assiut university Recruiting
Assiut, Egypt, 71516
Contact: Ahmed HH Amin    1060431973 ext +20    ahmed.hamada777@gmail.com   
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Ahmed HH Amin Assistant Lecturer
Study Chair: Fatma AA Ahmed Professor
Study Director: Eman AE Ahmed Assistant professor
Study Director: Ghada MA Abdelhamid Lecturer

Responsible Party: Ahmed Hamada Hamed, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03494595     History of Changes
Other Study ID Numbers: TEG PLT
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahmed Hamada Hamed, Assiut University:
Pediatric Liver Transplantation, Thromboelastometry

Additional relevant MeSH terms:
Liver Extracts
Hematinics