Randomized Study on the Effects of Moderate Anaemia in Fr... | NCT01848431

Studies
Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer

NCT01848431

Sponsor

University of Zurich

Status

Withdrawn

Last Update Posted

Nov 10, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Open Fracture of Foot
Tumor

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

staff change and lack of ressources

Expanded Access Info

Start Date

May 2013Estimated

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2018Actual

First Submitted Date

Apr 22, 2013

First Submission Date that Met QC Criteria

May 6, 2013

First Posted Date

May 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2020

Last Update Posted Date

Nov 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible reduction of the transfusion threshold.

Trial with surgical intervention

Detailed Description

In study group 1 patients will be kept at a hematocrit level below 28% and only receive transfusions if symptomatic or the fall below 25%. Patients in group 2 will receive transfusions to reach a hematocrit always above 30%.

Tissue perfusion in free flaps will be measured with indocyanine green fluorescence angiography, confocal microscopy and oxygen partial pressure measurement probes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
anaemia group		no blood transfusions will be given until hct falls under 25%
normal hct group		patients in group 2 will receive transfusions as is currently standard protocol outside the study

Interventions

Not provided

Measure	Description	Time Frame
Number of Blood transfusions peri- and postoperative		10 days

Eligibility Module

Eligibility Criteria

Inclusion criteria:

planned defect reconstruction with free flap and preoperative hematocrit of 28% or below

Exclusion criteria:

coagulation disorder
Jehovah's witness
iodine allergy
renal or hepatic insufficiency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients scheduled for defect reconstruction with free flaps and a preoperative hematocrit of 28 % or below

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maurizio Calcagni, MD	University Hospital Zurich, Clinic of Reconstructive Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Center for Reconstructive Surgery		Zurich	Canton of Zurich	8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided