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Effect of Colloid Versus Crystalloid on Coagulation

NCT ID: NCT01444508

Last Updated: 2013-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.

Detailed Description

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Conditions

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Bloodloss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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crystalloid

Group Type ACTIVE_COMPARATOR

Ringer-lactate "SAD"

Intervention Type DRUG

Lactated Ringer's is administrated intravenously in the dosis of max. 35 ml/kg during the operation after securing normovolaemia with Nexfin Monitor at induction of the anaesthesia: if bolus infusion of 200 ml increases stroke volume more than 10 % the patient is not assumed normovolaemic and bolus infusions are repeated until normovolaemic status is achieved.

colloid

Group Type PLACEBO_COMPARATOR

HES 130/04

Intervention Type DRUG

Voluven is administered intravenously in the doses of max. 35 ml/kg during the operation. Normovolaemia is achieved in the same way as described in intervention by Ringer-lactate "SAD".

Interventions

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Ringer-lactate "SAD"

Lactated Ringer's is administrated intravenously in the dosis of max. 35 ml/kg during the operation after securing normovolaemia with Nexfin Monitor at induction of the anaesthesia: if bolus infusion of 200 ml increases stroke volume more than 10 % the patient is not assumed normovolaemic and bolus infusions are repeated until normovolaemic status is achieved.

Intervention Type DRUG

HES 130/04

Voluven is administered intravenously in the doses of max. 35 ml/kg during the operation. Normovolaemia is achieved in the same way as described in intervention by Ringer-lactate "SAD".

Intervention Type DRUG

Other Intervention Names

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Ringer-laktat "SAD", B 05 BB 01, Amgros A/S. Voluven, HES 130/04, B 05 AA 07, Fresenius Kabi A/S.

Eligibility Criteria

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Inclusion Criteria

* Patient more than 18 years old
* Indication for elective post-renal operation including cystectomy
* Patient without anticoagulative, acetylsalicylic acid or NSAID treatment for the last 5 days.

Exclusion Criteria

* Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
* Pregnant or nursing
* Allergic
* Disturbance in electrolytes
* Patient under committee
* Patient joining another trial interfering the actual trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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K. C. Rasmussen

OTHER

Sponsor Role lead

Responsible Party

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K. C. Rasmussen

MD, specialist in surgery and research fellow

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Niels H Secher, Professor

Role: CONTACT

Phone: +45 3545 2242

Email: [email protected]

Kirsten C Rasmussen, MD

Role: CONTACT

Phone: +45 61335239

Email: [email protected]

Facility Contacts

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Niels Henry Secher, Professor

Role: primary

References

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Rasmussen KC, Johansson PI, Hojskov M, Kridina I, Kistorp T, Thind P, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial. Ann Surg. 2014 Feb;259(2):249-54. doi: 10.1097/SLA.0000000000000267.

Reference Type DERIVED
PMID: 24100337 (View on PubMed)

Other Identifiers

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2011-003270-80

Identifier Type: -

Identifier Source: org_study_id