NCT02108093

Brief Summary

The effect of retrograde autologous priming (RAP) on regional cerebral oxygenation (rSO2) still remains unclear, because studies are limited in sample size and study design, and because of the absence of prospective studies. The investigators hypothesize that RAP limits the degree of hemodilution and thereby limits prolonged intraoperative cerebral desaturation during cardiopulmonary bypass (CPB), compared to the conventional priming method. The primary objective of this study is to determine whether RAP limits the degree of hemodilution and limits prolonged intraoperative cerebral desaturation during cardiopulmonary bypass, compared to the conventional priming method. Prolonged intraoperative cerebral desaturation will be assessed by rSO2 desaturation score50. rSO2 desaturation score50 \> 3000 is associated with increased risk of cognitive decline. The investigators hypothesize that RAP limits the degree of hemodilution and thereby limits the incidence of rSO2 desaturation score50 \> 3000 with a relative difference of 50%. The subjects who are divided in the RAP group, the retrograde autologous priming technique will be used, where the patient's own circulating blood partially will be replaced by the priming solution in the cardiopulmonary bypass. In the Control group the conventional priming method will be used. The main study parameters is rSO2 desaturation score50.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

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 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 25, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

April 5, 2014

Last Update Submit

December 24, 2014

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • prolonged intraoperative cerebral desaturation

    The primary study parameter of this study is prolonged intraoperative cerebral desaturation and will be assessed by rSO2 desaturation score50. rSO2 desaturation score50 \> 3000 is associated with increased risk of cognitive decline. Formula described by Slater et al. : rSO2 score = 50% rSO2 - current rSO2 (%) x time (s) will be used to calculate the rSO2 score; from the intraoperative cerebral oximetry data.

    Participants will be followed for the duration of the operation period, an expected average of 3 hours

Secondary Outcomes (3)

  • cerebral oxygenation desaturation episodes (CODE)

    participants will be followed for the duriation of the operation period, an expected average of 3 hours

  • Subjective Cognitive Failure Questionnaire (CFQ)

    3 months and 6 months after randomization

  • blood transfusions (amount)

    participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Study Arms (2)

RAP (retrograde autologous priming) group

EXPERIMENTAL

In the RAP (retrograde autologous priming) group, the priming solution is partially replaced by the patient's own circulating blood, before initiation of CPB. After initiation of cardiopulmonary bypass the priming volume is approximately 900 ml.

Procedure: retrograde autologous priming

Control group

NO INTERVENTION

In the control group, the priming volume of the arterial and venous line will not be replaced by patient's own blood. The priming volume of cardiopulmonary bypass is 1300 ml in the control group.

Interventions

retrograde autologous primingPROCEDURE

Retrograde autologous priming (RAP) is a technique where, the patient's own circulating blood partially replaces the priming solution in the CPB.

Also known as: RAP
RAP (retrograde autologous priming) group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elective combined cardiac surgical procedures

You may not qualify if:

  • Elective single cardiac surgical procedures
  • off-pump procedure
  • re-operation
  • emergency operation
  • methylene blue administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amphia Hospital

Breda, 4800 RK, Netherlands

RECRUITING

Related Publications (5)

  • Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.

    PMID: 19101265BACKGROUND

  • de Tournay-Jette E, Dupuis G, Bherer L, Deschamps A, Cartier R, Denault A. The relationship between cerebral oxygen saturation changes and postoperative cognitive dysfunction in elderly patients after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):95-104. doi: 10.1053/j.jvca.2010.03.019. Epub 2010 Jul 22.

    PMID: 20650659BACKGROUND

  • Murkin JM. Pathophysiological basis of CNS injury in cardiac surgical patients: detection and prevention. Perfusion. 2006 Jul;21(4):203-8. doi: 10.1191/0267659106pf869oa.

    PMID: 16939113BACKGROUND

  • Hwang J, Huh J, Kim J, Park S, Hwang J, Nahm FS, Hahn S. The effect of retrograde autologous priming of the cardiopulmonary bypass circuit on cerebral oxygenation. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):995-9. doi: 10.1053/j.jvca.2011.02.017. Epub 2011 May 14.

    PMID: 21576024BACKGROUND

  • Anastasiadis K, Argiriadou H, Kosmidis MH, Megari K, Antonitsis P, Thomaidou E, Aretouli E, Papakonstantinou C. Neurocognitive outcome after coronary artery bypass surgery using minimal versus conventional extracorporeal circulation: a randomised controlled pilot study. Heart. 2011 Jul;97(13):1082-8. doi: 10.1136/hrt.2010.218610. Epub 2011 Feb 28.

    PMID: 21357641BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Thierry Scohy, MD, PhD

    Amphia Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorien Kimenai, Bsc

CONTACT

dkimenai@amphia.nl

Thierry Scohy, MD, PhD

CONTACT

tscohy@amphia.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 5, 2014

First Posted

April 9, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 25, 2014

Record last verified: 2014-12

Locations

NL(1)