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Effect of Colloid Versus Crystalloid on Coagulation

Primary Purpose

Bloodloss

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ringer-lactate "SAD"
HES 130/04
Sponsored by
K. C. Rasmussen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bloodloss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

crystalloid

colloid

Arm Description

Outcomes

Primary Outcome Measures

Effect of colloid versus crystalloid on laboratory coagulation.
Coagulation is analysed in bloodsamples before, during (10 minutes post cystectomia), at the end of the operation and 2 hours later on. The bloodsamples are analysed by thromboelastography (5000 series TEG analyzer, Haemoscope Corporation, Niles IL, USA) besides the classic coagulation parametres: platelet count, INR, Fibrinogen, APTT, D-dimer and Haemoglobin, Amylase and Creatinin.

Secondary Outcome Measures

Effect of colloid versus crystalloid on the amount of bloodloss
The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on.

Full Information

First Posted
September 10, 2011
Last Updated
December 12, 2013
Sponsor
K. C. Rasmussen
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1. Study Identification

Unique Protocol Identification Number
NCT01444508
Brief Title
Effect of Colloid Versus Crystalloid on Coagulation
Official Title
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
K. C. Rasmussen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bloodloss

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
crystalloid
Arm Type
Active Comparator
Arm Title
colloid
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ringer-lactate "SAD"
Other Intervention Name(s)
Ringer-laktat "SAD", B 05 BB 01, Amgros A/S.
Intervention Description
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
Intervention Name(s)
HES 130/04
Other Intervention Name(s)
Voluven, HES 130/04, B 05 AA 07, Fresenius Kabi A/S.
Intervention Description
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".
Primary Outcome Measure Information:
Title
Effect of colloid versus crystalloid on laboratory coagulation.
Description
Coagulation is analysed in bloodsamples before, during (10 minutes post cystectomia), at the end of the operation and 2 hours later on. The bloodsamples are analysed by thromboelastography (5000 series TEG analyzer, Haemoscope Corporation, Niles IL, USA) besides the classic coagulation parametres: platelet count, INR, Fibrinogen, APTT, D-dimer and Haemoglobin, Amylase and Creatinin.
Time Frame
5-7 hours
Secondary Outcome Measure Information:
Title
Effect of colloid versus crystalloid on the amount of bloodloss
Description
The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on.
Time Frame
5-7 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niels H Secher, Professor
Phone
+45 3545 2242
Email
nielsh.secher@rh.regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten C Rasmussen, MD
Phone
+45 61335239
Ext
+45 35458735
Email
dockcr@yahoo.com
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels Henry Secher, Professor
Phone
+45 35452242
Email
niels.h.secher@rh.regionh.dk

12. IPD Sharing Statement

Citations:
PubMed Identifier
24100337
Citation
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.
Results Reference
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Effect of Colloid Versus Crystalloid on Coagulation

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