NCT02771223

Brief Summary

Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation abnormalities, most of which related to the direct, time dependent effect of the polymer tubing and the pump rollers on the thrombocytes. Significant evidence demonstrates the effect of the duration of cardiopulmonary bypass on thrombocytes number and function, as well as on postoperative coagulopathy

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

April 22, 2016

Last Update Submit

May 13, 2016

Conditions

Coagulopathy

Outcome Measures

Primary Outcomes (2)

  • Change in Platelet function apoptosis markers

    Platelet apoptosis by annexin V (Flow cytometry)

    1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB

  • Change in Platelet function activation markers

    Platelet activation by P-selectin (Flow cytometry)

    1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB

Secondary Outcomes (1)

  • Change in platelet count over time

    Every 30 minutes - starting less than 10 minutes after induction of anesthesia, and for 7 hours or until termination of CPB and protamine administration - whichever comes first

Study Arms (1)

Study group

patients scheduled for prolonged cardiac surgery (over 3 hours anticipated ECC time) with no known coagulation disorders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults over 18 yo scheduled for prolonged cardiac surgery requiring ECC time over 3 hours,

You may qualify if:

  • adults over 18 yo
  • scheduled for prolonged cardiac surgery requiring ECC time over 3 hours

You may not qualify if:

  • documented coagulopathy
  • antiplatelet therapy other then aspirin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pediatric Anesthesia

Study Record Dates

First Submitted

April 22, 2016

First Posted

May 13, 2016

Study Start

May 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

May 17, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share