Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery

NCT00359398 | Terminated Phase 2 DMC

• 1 other identifier: 2006IC003B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Excessive bleeding is common after cardiac surgery. This may result in patients receiving a blood transfusion or suffering the life-threatening complication of cardiac tamponade. Tamponade is when excessive bleeding compresses the heart and prevents it from pumping properly. A major reason for the bleeding is the damage done to platelets by the cardiopulmonary bypass (CPB) machine. Often patients receive platelets and plasma from blood donors to try to reduce the bleeding post-operatively. The investigators plan to take platelets and plasma from patients before they are damaged. They would then return these 'undamaged' sequestered platelets to the patients after the bypass machine is no longer needed. Therefore, the investigators' primary question is whether platelet sequestration would reduce the bleeding problems that occur following cardiac surgery. They will evaluate bleeding problems using thromboelastography, which provides a comprehensive assessment of both how blood clots form and their strength. If sequestration reduces bleeding problems following cardiac surgery then it may reduce the chance of patients receiving blood products from donors. Although donated blood is thoroughly tested, its use does expose patients to the risk of transfusion errors, blood borne infections and reactions. Avoiding its use would be very desirable.

Conditions

Cardiac Surgical Procedures; Cardiopulmonary Bypass; Blood Platelet Disorders; Blood Coagulation Disorders

Keywords

Cardiopulmonary bypass; Blood component removal

Outcome Measures

Primary Outcomes (1)

• Incidence of coagulation abnormalities as assessed by thromboelastography and platelet function analyser

  At end of surgery (usually <1 day)

Secondary Outcomes (5)

• Volume of blood lost into chest drains during first 24 post-operative hours

  24 hours

• Volume of blood product administered during first 24 post-operative hours

  24 hours

• Length of stay in the intensive care unit (ICU)

  Usually < 30 days

• ICU mortality

  Usually < 30 days

• Incidence of surgical re-exploration

  Hospital admission (usually < 30 days)

Study Arms (2)

Platelet sequestration

EXPERIMENTAL

Sequestration of platelet rich plasma before cardiopulmonary bypass

Procedure: Platelet rich plasma sequestration

Standard care

NO INTERVENTION

No platelet rich plasma sequestration undertaken before cardiopulmonary bypass (usual practice)

Interventions

Platelet rich plasma sequestration PROCEDURE

Venesection of blood (14 ml/kg) and separation to red cells and platelet rich plasma.

Also known as: Haemonetics cell salavage system

Platelet sequestration

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing cardiac surgery that involves:
• Repeat median sternotomy
• Mitral valve repair
• Double valve operations
• Combined valve and coronary surgery
• Anticipated prolonged cardiopulmonary bypass

You may not qualify if:

• Pre-operative anaemia
• Pre-operative thrombocytopenia
• Unstable angina
• Anti-platelet therapy (e.g. aspirin, clopidogrel) within the previous 7 days
• Known or symptomatic cerebrovascular disease
• Known disorders of haemostasis
• Aprotinin sensitivity
• Pregnancy.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, SW3 6LY, United Kingdom

Location

MeSH Terms

Conditions

Blood Platelet Disorders; Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Simon J Finney, MBChB, PhD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Andrea Kelleher, MBBS

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Judith Hall

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Simon Davidson, PhD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 2, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

GB (1)