NCT02461329

Brief Summary

The purpose of the study is to determine whether volume therapy with a solution of gelatine has negative impact on coagulation, platelet function, renal function in comparison with crystaloid solution (Ringerfundin).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

April 16, 2015

Last Update Submit

June 2, 2015

Conditions

Hemorrhage, SurgicalHip Replacement, TotalThrombocytopathy

Keywords

Hip Replacement, TotalGelatine solutionBalanced Crystaloid SolutionVolume therapyPlatelet aggregation

Outcome Measures

Primary Outcomes (1)

  • Change of coagulation status and platelet function

    Before and after the surgery (in OR) the investigator will obtain a blood sample from subject, standard coagulation test will be performed (INR, PT, aPTT, thrombin time), the investigator will perform ROTEM tests: EXTEM, INTEM and FIBTEM assay and blood sample will be tested for thrombocyte function - aggregation with ADP, collagen, epinephrine, TRAP - thrombin receptor-activated peptide.

    perioperative, an expected average of 2 hours

Secondary Outcomes (3)

  • Blood loss

    perioperative, an expected average of 2 hours

  • Renal function

    2 days after surgery

  • Transfusion needs

    hospital stay, an expected average of 1 week

Other Outcomes (1)

  • Perioperative complications

    hospital stay, an expected average of 1 week

Study Arms (2)

Gelatine solution

EXPERIMENTAL

Gelofusine will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease). The blood pressure and heart rate before and after fluid challenge will be recorded.

Drug: Gelofusine® B. Braun

Balanced Crystaloid solution

EXPERIMENTAL

Ringerfundin will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease). The blood pressure and heart rate before and after fluid challenge will be recorded.

Drug: Ringerfundin ® B. Braun

Interventions

Gelofusine® B. BraunDRUG

Volume therapy by Gelatine solution infusion via intravenous boluses to achieve hemodynamic targets

Gelatine solution
Ringerfundin ® B. BraunDRUG

Volume therapy by Balanced Crystaloid solution solution infusion via intravenous boluses to achieve hemodynamic targets

Balanced Crystaloid solution

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient scheduled for elective hip replacement surgery
  • age between 19-85 years
  • signed informed consent

You may not qualify if:

  • informed consent not signed
  • traumatic hip fracture
  • anemia (hemoglobin level \< 100 g/l)
  • allergy to study drug and/or multiple allergies
  • chronic heart failure with LVEF \< 30%
  • shock states
  • coagulopathy
  • thrombocytopenia
  • thrombocytopathy
  • chronic kidney disease with oliguria
  • chronic antiplatelet drug medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Blood Loss, SurgicalBlood Platelet Disorders

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Milan Kratochvil, MD

    FN Brno

    PRINCIPAL INVESTIGATOR

  • Milan Kratochvil, MD

    FN Brno

    STUDY DIRECTOR

  • Roman Gál, Prof, MD, Ph.D

    Fn Brno

    STUDY CHAIR

Central Study Contacts

Milan Kratochvil, MD

CONTACT

+420532232009mkratochvil@fnbrno.cz

Jozef Klučka, MD

CONTACT

+420775467052jozefklucka@seznam.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research coordinator

Study Record Dates

First Submitted

April 16, 2015

First Posted

June 3, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

June 3, 2015

Record last verified: 2015-06