Effect of Colloid Versus Crystalloid on Coagulation in El... | NCT02009033

Studies
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

NCT02009033

Sponsor

K. C. Rasmussen

Status

Completed

Last Update Posted

Dec 11, 2013Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Disorders of Coagulation

Interventions

Lactated Ringer
Hydroxyethylstarch

Countries

Not provided

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 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Apr 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 18, 2011

First Submission Date that Met QC Criteria

Dec 6, 2013

First Posted Date

Dec 11, 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

Dec 6, 2013

Last Update Posted Date

Dec 11, 2013Estimated

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 purpose of this study is to investigate the effect of thin fluid with starch versus thin fluid without starch on coagulation in elective surgery when the patient is normovolæmic during operation.

Detailed Description

The primary goal is to register coagulation on basis of blood samples inclusive thromboelastography results.

The secondary goal is to register blood loss and use of blood products during operation.

The trial concerns 40 patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ringer's lactate	Experimental	Fluid therapy during operation	Drug: Lactated Ringer Drug: Hydroxyethylstarch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactated Ringer	Drug	When normovolæmic status of the patient is secured, 35 ml/kg of the allocated fluid is infused during the operation (estimated time for this type of operation is 180 minutes), however max. 3500 ml.Lactated Ringer is the interventional medication.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimate coagulation on basis of bloodsamples		6 months

Secondary Outcomes

Measure	Description	Time Frame
Estimate coagulation by bloodloss and need for transfusion		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient older than 18 years.
Indication for elective surgery with removal of the urine bladder.
Patient without anticoagulative, acethylsalisylsyre or NSAID medicine during the last 5 days,if using.

Exclusion Criteria:

Cerebral haemorrhage
Renal insufficiency demanding dialysis
Manifest cardiac and hepatic insufficiency
Disturbance in coagulation
Hypernatriæmi
Hyperchloræmi
Pregnant or nursing
Allergic to hydroxyethylstarch
Participating in another trial-if interferring the present trial
Incapable of managing his own affairs.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Niels Henry Secher, Professor	Rigshospitalet , Dept. 2042, 2100 Copenhagen	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020141	Hemostatic Disorders

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006474	Hemorrhagic Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077325	Ringer's Lactate
D006895	Hydroxyethyl Starch Derivatives

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided