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Trial registered on ANZCTR


Registration number
ACTRN12612000691842
Ethics application status
Approved
Date submitted
6/06/2012
Date registered
27/06/2012
Date last updated
27/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dynamic changes in clot formation using Thromboelastometry after reinfusion of unwashed cell salvaged whole blood in total hip arthroplasty: a pilot study
Scientific title
Dynamic changes in clot formation using Thromboelastometry after reinfusion of unwashed cell salvaged whole blood in total hip arthroplasty
Secondary ID [1] 280632 0
nil
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shed blood 286644 0
reinfusion 286794 0
clot formation 286796 0
coagulopathy 286797 0
Condition category
Condition code
Blood 286928 286928 0 0
Clotting disorders
Surgery 287105 287105 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
to evaluate if the reinfusion of cellsalvaged whole blood will impact on coagulation observed in standard laboratory testing and/or thrombelasometry. A minimum of 300ml blood is collected during hip replacement surgery using the SANGVIA cell saver system, filtered and then reinfused immediately post-operatively
Intervention code [1] 285028 0
Treatment: Other
Intervention code [2] 285172 0
Treatment: Surgery
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287283 0
standard coagulation test (INR/aPPT) and assessed using point of care device, "ROTEM".thrombelastometry in addition to cytokine analysis of the collected blood
Timepoint [1] 287283 0
outcome assessed at one time point within 1 hour of postoperative reinfusion of intraoperative cellsalvaged blood
Secondary outcome [1] 297820 0
haemoglobin post op
Timepoint [1] 297820 0
post op day one or two
Secondary outcome [2] 298121 0
haemoglobin at discharge
Timepoint [2] 298121 0
Hb closest to discharge
Secondary outcome [3] 298122 0
allogeneic transfusion of red blood cells
Timepoint [3] 298122 0
this hospital stay
Secondary outcome [4] 298123 0
cytokines in salvaged blood before reinfusion
Timepoint [4] 298123 0
analysed post completion

Eligibility
Key inclusion criteria
primary hip replacement
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
contraindication to reinfusion of shed blood, pateint refusal,
pre-existing coagulopathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
consented patients for primary hip arthroplasty
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285397 0
Commercial sector/Industry
Name [1] 285397 0
Astra Tech AB
Country [1] 285397 0
Sweden
Funding source category [2] 285398 0
Government body
Name [2] 285398 0
BloodSafe
Country [2] 285398 0
Australia
Funding source category [3] 285399 0
Commercial sector/Industry
Name [3] 285399 0
HaemoVIEW Diagnostics Pty Ltd
Country [3] 285399 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Astra Tech AB
Address
PO Box 14
SE-431 21
Country
Sweden
Secondary sponsor category [1] 284250 0
Commercial sector/Industry
Name [1] 284250 0
HaemoVIEW Diagnostics Pty Ltd
Address [1] 284250 0
HaemoVIEW Diagnostics Pty Ltd
73 Osna Place
Pullenvale
Brisbane 4069
Queensland
Country [1] 284250 0
Australia
Secondary sponsor category [2] 284251 0
Government body
Name [2] 284251 0
BloodSafe
Address [2] 284251 0
301 Pirie Street
Adelaide
South Australia
5000
Country [2] 284251 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287412 0
ETHICS OF HUMAN RESEARCH COMMITTEE (TQEH & LMH)
Ethics committee address [1] 287412 0
Executive Officer, Human Research Ethics Committee

The Queen Elizabeth Hospital, Lyell McEwin Hospital & Modbury Hospital
Adelaide Health Service

Ground Floor, Basil Hetzel Institute for Medical Research, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South SA 5011
Ethics committee country [1] 287412 0
Australia
Date submitted for ethics approval [1] 287412 0
Approval date [1] 287412 0
03/06/2011
Ethics approval number [1] 287412 0
NA

Summary
Brief summary
A pilot study:
As part of our standard care, in line with a comprehensive blood management approach, patients presenting for primary hip arthroplasty are offered intra-operative cell salvage. One type of cell saver used is the SANGVIA system. Blood is collected during surgery, filtered and can be reinfused post-operatively. This is a relatively new technology and there is some controversy around the efficacy, safety and potential adverse effects of the reinfusion. This includes some concern whether a coagulopathy might be induced by reinfusion through various mechamisms. of cytokines.
A "point of care device" "ROTEM" is well established in clinical medicine. It is comprehensive diagnostic system coagulation management.
We would like to assess the patients' clotting profile before incision and the potential impact of reinfusion of the salvaged blood at the end of the operation. This will be conducted with ROTEM , testing for ex-TEM S (screening extrinsic clotting pathway & platelet contribution to clot formation), in-TEM S (screening intrinsic clotting pathway & platelet contribution to clot formation)compared to standard Lab testing (INR, aPTT).
A small sample volume of the shed blood is collected and analyed for haemoglobin and platelets to assess the quality and composition of the blood. In addition a 2nd sample is frozen which will be analyzed after completion of the study to assess the presence and levels of imflammatory mediators.
Trial website
nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34279 0
Address 34279 0
Country 34279 0
Phone 34279 0
Fax 34279 0
Email 34279 0
Contact person for public queries
Name 17526 0
Dr Bernd Froessler
Address 17526 0
Dept of Anaesthesia
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale SA 5112
Country 17526 0
Australia
Phone 17526 0
+61881829806
Fax 17526 0
Email 17526 0
[email protected]
Contact person for scientific queries
Name 8454 0
Dr Bernd Froessler
Address 8454 0
Dept of Anaesthesia
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale SA 5112
Country 8454 0
Australia
Phone 8454 0
+61881829806
Fax 8454 0
Email 8454 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDynamic changes in clot formation determined using thromboelastometry after reinfusion of unwashed anticoagulated cell-salvaged whole blood in total hip arthroplasty.2015https://dx.doi.org/10.2450/2015.0311-14
N.B. These documents automatically identified may not have been verified by the study sponsor.