NCT03818113

Brief Summary

Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution). This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

January 23, 2019

Last Update Submit

November 5, 2019

Conditions

Mitral Valve Reconstruction

Keywords

mitral valve insufficiencycardioplegiacardioplegia SolutionHTK-Bretschneider (Custidiol®) solutionSt. Thomas solutioncardiac biomarker

Outcome Measures

Primary Outcomes (3)

  • high specific troponin T (hs-TrT) (μg/l)

    cardial biomarker for myocardial damage

    perioperative during minimal invasive surgery

  • Creatin-Phosphokinase (CK) (U/l)

    cardial biomarker for myocardial damage

    perioperative during minimal invasive surgery

  • Creatinkinase Muscle- Brain (CK-MB) (U/l)

    cardial biomarker for myocardial damage

    perioperative during minimal invasive surgery

Secondary Outcomes (2)

  • mortality rate

    from minimal invasive surgery until 30 days post surgery

  • length of stay in intensive care unit (days)

    from minimal invasive surgery until 30 days post surgery

Study Arms (2)

HTK-Bretschneider cardioplegic solution

Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with HTK-Bretschneider cardioplegic solution

Other: cardioplegia with HTK-Bretschneider cardioplegic solution

St. Thomas cardioplegic solution

Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with St. Thomas cardioplegic solution

Other: cardioplegia with St. Thomas cardioplegic solution

Interventions

cardioplegia with HTK-Bretschneider cardioplegic solutionOTHER

cardioplegia with HTK-Bretschneider cardioplegic solution

HTK-Bretschneider cardioplegic solution
cardioplegia with St. Thomas cardioplegic solutionOTHER

cardioplegia with St. Thomas cardioplegic solution

St. Thomas cardioplegic solution

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with mitral valve reconstruction done via minimal invasive antero- lateral thoracotomy (2009-2018) at Universitätsspital Basel.

You may qualify if:

  • Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

You may not qualify if:

  • Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Herzchirurgie, Universitätsspital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Heart Arrest, Induced

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Martin Grapow, Prof. Dr.

    Klinik für Herzchirurgie, Universitätsspital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 28, 2019

Study Start

April 1, 2019

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

November 6, 2019

Record last verified: 2019-11

Locations

CH(1)