Effect of Colloid Versus Crystalloid on Coagulation

NCT01444508 | Unknown Phase 4

• 1 other identifier: 2011-003270-80
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bloodloss

Outcome Measures

Primary Outcomes (1)

• 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.

  5-7 hours

Secondary Outcomes (1)

• Effect of colloid versus crystalloid on the amount of bloodloss

  5-7 hours

Study Arms (2)

crystalloid

ACTIVE COMPARATOR

Drug: Ringer-lactate "SAD"

colloid

PLACEBO COMPARATOR

Drug: HES 130/04

Interventions

Ringer-lactate "SAD" 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.

Also known as: Ringer-laktat "SAD", B 05 BB 01, Amgros A/S.

crystalloid

HES 130/04 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".

Also known as: Voluven, HES 130/04, B 05 AA 07, Fresenius Kabi A/S.

colloid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• K. C. Rasmussen: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 24100337 DERIVED

MeSH Terms

Interventions

HES 130-0.4

Central Study Contacts

Niels H Secher, Professor

CONTACT

+45 3545 2242; nielsh.secher@rh.regionh.dk

Kirsten C Rasmussen, MD

CONTACT

+45 61335239; dockcr@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, specialist in surgery and research fellow

Study Record Dates

• First Submitted: September 10, 2011
• First Posted: September 30, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

DK (1)