NCT02441751

Brief Summary

QT interval changes is measured during all phases of the operation. The protocol is focusing at intraoperative bleeding events and is also observing QT interval changes during anesthetic and operative procedures.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

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

Study Start

First participant enrolled

May 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

8.2 years

First QC Date

May 8, 2015

Last Update Submit

March 30, 2022

Conditions

Blood Loss, Surgical

Keywords

ElectrocardiographyHemorrhageMonitoring, Intraoperative

Outcome Measures

Primary Outcomes (1)

  • change in QT-time

    during operation

Secondary Outcomes (2)

  • postoperative incidents/disturbance rhythm of the heart

    2 days

  • survival

    1 year

Study Arms (2)

bleeding

intraoperative blood loss \> 500 ml

Procedure: intra-operative blood loss

no bleeding

intraoperative blood loss \< 500 ml

Interventions

intra-operative blood lossPROCEDURE

surgery in the urology and orthopedics

bleeding

Eligibility Criteria

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

patients for major surgery in urology and orthopedics

You may qualify if:

  • American Society of Anesthesiologists physical status classification 2 - 3
  • patients after consent

You may not qualify if:

  • Children,
  • pregnant women,
  • patients not able to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Anesthesia and Intensive Care, University Hospital, Technische Universität Dresden

Dresden, 01307, Germany

RECRUITING

Related Publications (1)

  • Straus SM, Kors JA, De Bruin ML, van der Hooft CS, Hofman A, Heeringa J, Deckers JW, Kingma JH, Sturkenboom MC, Stricker BH, Witteman JC. Prolonged QTc interval and risk of sudden cardiac death in a population of older adults. J Am Coll Cardiol. 2006 Jan 17;47(2):362-7. doi: 10.1016/j.jacc.2005.08.067.

    PMID: 16412861BACKGROUND

MeSH Terms

Conditions

Blood Loss, SurgicalHemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Study Officials

  • Torsten Richter, M.D.

    University Hospital Dresden, TU Dresden

    STUDY DIRECTOR

Central Study Contacts

Torsten Richter, M.D.

CONTACT

004935145818034torsten.richter@uniklinikum-dresden.de

Juliane Flaxa, M.D.

CONTACT

0049351458juliane.flaxa@uniklinikum-dresden.de

Study Design

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

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 12, 2015

Study Start

May 1, 2015

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

DE(1)