Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT02410473|
Recruitment Status : Active, not recruiting
First Posted : April 7, 2015
Last Update Posted : April 22, 2019
|Condition or disease||Intervention/treatment|
|Congenital Heart Disease||Other: Discarded blood samples Other: Discarded Urine Sample|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2020|
- Other: Discarded blood samples
Will utilize the discarded blood from routine clinical blood samples to evaluate the input of the newer technologies that helped for the diagnostic of coagulopathy.
- Other: Discarded Urine Sample
Will utilized the discarded urine samples from the routinely placed Foley catheter to measure the indices of oxidative stress.
- Evaluate newer technologies for coagulation diagnostics with the aim to standardize bleeding management in high risk cardiac patients [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
Collect discarded blood from 4 routine blood samples. These will be obtained at 4 different time-points: 1. After induction of anesthesia and placement of arterial line, 2. After cardiopulmonary Bipass (CPB), 3 minutes after protamine administration, 3. At the end of the surgery, before transfer to CICU, 4. 24- 48 hrs post-surgery in the ICU.
Collect two 5 mL of urine samples. One sample prior to CPB, as well as following CPB, from an routinely placed Foley catheter.
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): NCT02410473
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Juan Ibla, MD||Boston Children’s Hospital|