PrOtamIne doSing clOt imagiNg (POISON) Study

NCT06421792 | Not Yet Recruiting

• 1 other identifier: T03024
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study involves using two different high-resolution microscopic imaging techniques to examine the health and platelet invasion of clot in patients who were given 1:1 protamine / heparin and compare this to clot from patients who had heparin reversed using the PRODOSE algorithm. Patients will be treated according to the routine clinical practice of their individual care team.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• High-resolution microscopic images (Scanning Electron Microscopy and Confocal Imaging)

  The proposed study involves using two different high-resolution microscopic imaging techniques to examine the health and platelet invasion of clot in patients who were given 1:1 protamine / heparin and compare this to clot from patients who had heparin reversed using the PRODOSE algorithm. This is an observational study in which differences between images of clot obtained from samples from the two patient groups and before and after cardiopulmonary bypass will be described.

  Pre Heparin and Post Protamine [5 minutes after heparin has been reversed]

Study Arms (2)

Standard

10 patients receiving standard reversal with 1:1 protamine / heparin ratio

PRODOSE Algorithm

10 patients who had heparin reversed using the PRODOSE algorithm anticipated (average protamine / heparin ratio 0.6:1).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective, uncomplicated single procedure cardiac surgery with anticipated CPB duration \< 120 min

You may qualify if:

• undergoing elective, uncomplicated single procedure cardiac surgery with anticipated CPB duration \< 120 min
• with all anticoagulant drugs stopped at least 5 days before surgery, apart from aspirin
• with normal full blood count and clotting screen pre-OP.

You may not qualify if:

• emergency surgery
• inability to stop anticoagulants except aspirin for 5 days pre-OP
• complex surgery with anticipated CPB duration \> 120min
• operations planned to be done at temperature on CPB \< 34 degrees
• operations requiring deep hypothermic circulatory arrest, solid organ transplantation
• know blood dyscrasia
• intra-operative blood or blood product transfusion or post-operative coagulopathy

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• University of Oxford: collaborator
• University of Liverpool: collaborator
• Medical Research Council: collaborator

Study Sites (1)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

Related Publications (1)

• Miles LF, Burt C, Arrowsmith J, McKie MA, Villar SS, Govender P, Shaylor R, Tan Z, De Silva R, Falter F. Optimal protamine dosing after cardiopulmonary bypass: The PRODOSE adaptive randomised controlled trial. PLoS Med. 2021 Jun 7;18(6):e1003658. doi: 10.1371/journal.pmed.1003658. eCollection 2021 Jun.

  PMID: 34097705 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: May 20, 2024
• Study Start: May 8, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)