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Trial registered on ANZCTR


Registration number
ACTRN12614000691640
Ethics application status
Not yet submitted
Date submitted
12/06/2014
Date registered
1/07/2014
Date last updated
1/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The administration of fibrinogen concentrate (a component of blood involved in clotting process) to be given to those women who, after delivery of babies, develop severe bleeding to establish if this drug will prevent further blood loss or reduce the volume of blood loss.
Scientific title
The effect of Upfront Administration of Fibrinogen concentrate on total blood volume loss in Obstetric Haemorrhage – A Pilot study
Secondary ID [1] 284792 0
nil
Universal Trial Number (UTN)
U 1111-1157-9979
Trial acronym
FIB-UPFRONT PPH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post partum haemorrhage 292166 0
Condition category
Condition code
Reproductive Health and Childbirth 292506 292506 0 0
Childbirth and postnatal care
Blood 292581 292581 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of Fibrinogen concentrate 4g given intra-venously upfront in women after delivery with a post partum blood loss of more than 1000mls and with signs of ongoing bleeding.
Intervention code [1] 289582 0
Treatment: Drugs
Comparator / control treatment
Placebo - Saline intra-venously
Control group
Placebo

Outcomes
Primary outcome [1] 292365 0
Efficacy
25% reduction in total measured blood volume loss. Blood loss is currently measured by means of collection via suction catheter to collection bags and weighing of swabs. Estimation/ measurement of amniotic fluid noted. For study we aim for the process to be as accurate as possible. We plan to use obstetric specific bags for blood loss during delivery/ collection via suction collection/ weighing of swabs . To compare volume blood loss measured we will correlate volume loss by calculating starting haemoglobin, to post bleed haemoglobin and include fluid and blood and products administered.
Timepoint [1] 292365 0
24 hours
Secondary outcome [1] 308785 0
Incidence of moderate PPH (blood loss between 1000 and 2000ml)
Timepoint [1] 308785 0
12 months (study period)
Secondary outcome [2] 308960 0
Incidence of severe PPH (blood loss >2000 ml)
Timepoint [2] 308960 0
12 months (study period)
Secondary outcome [3] 308961 0
Total blood product usage
Timepoint [3] 308961 0
24hrs
Secondary outcome [4] 308962 0
Activation of Massive transfusion protocol. (MTP)
Timepoint [4] 308962 0
24 hrs
Secondary outcome [5] 308963 0
Need for haemostatic intervention (balloon tamponade, uterine artery embolization, surgical arterial ligation, hysterectomy)
Timepoint [5] 308963 0
24 hrs
Secondary outcome [6] 308964 0
Anaemia with Hb <80 g/L at 24 hours post delivery

(Blood test at 24hrs)
Timepoint [6] 308964 0
24 hrs
Secondary outcome [7] 308965 0
Admission to ICU/ DCCM
Timepoint [7] 308965 0
6months
Secondary outcome [8] 308966 0
Maternal mortality
Timepoint [8] 308966 0
6 months
Secondary outcome [9] 308967 0
Infection rates (wound infection, endometritis, pneumonia)
(review hospital notes, clinic follow up, re-admission)
Timepoint [9] 308967 0
3 months
Secondary outcome [10] 308968 0
Breast feeding rates at hospital discharge and at 6 weeks
(Questionnaire)
Timepoint [10] 308968 0
6 weeks
Secondary outcome [11] 308969 0
Quality of life indicators as per WHODAS 2.0/ post-traumatic stress disorder score at 6 weeks
Timepoint [11] 308969 0
6 weeks
Secondary outcome [12] 309107 0
Anaemia at 6 weeks postpartum (Hb <100 g/L)
Timepoint [12] 309107 0
Blood test at 6 weeks

Eligibility
Key inclusion criteria
Insure both criteria 1) and 2) are satisfied;
1. Women with estimated blood loss greater than 1000mL in the immediate postpartum period (<4 hours postpartum).
2. Women with persistent PPH not responding to first line uterotonic therapy (i.e. syntocinon infusion), and manual uterine compression in whom further haemostatic intervention is being considered.
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1)Women with coagulopathic disorder secondary to pre-existing liver disease.
2)Women with confirmed venous thromboembolism occurring in the last 4 weeks of pregnancy
3)Women with confirmed allergy to fibrinogen concentrate
4)Woman who refuse blood products

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Postpartum haemorrhage is an unanticipated sudden complication of delivery and approaching women for informed consent for the first time when they develop PPH is unlikely to offer sufficient time to fully discuss the implications of the proposed intervention. We plan to provide written information sheets to women in the third trimester of pregnancy who are planning to deliver in the study sites when they attend routine antenatal visits. Woman booked with hospital LMC and private obstetricians and independent midwives will receive study information and will be eligible for enrolment.
Written consent will be obtained from all women who would be willing to participate either during the third trimester or when the woman presents to the labour ward.
We anticipated that the majority of women will indicate consent in advance of labour but will be able to withdraw at any stage. The consent form will be filed in an easily accessibly place, in the front of the participants’ hospital antenatal notes. This method ensures that women will be given the necessary information and can therefore provide informed consent with full mental capacity prior to the Intervention development of a PPH. In case of PPH and after eligibility is confirmed, women will be allocated to either standard of care and placebo or treatment arm: 4mg of fibrinogen and standard of care. Allocation concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
245
Accrual to date
Final
Recruitment outside Australia
Country [1] 6137 0
New Zealand
State/province [1] 6137 0
Auckland

Funding & Sponsors
Funding source category [1] 289408 0
Hospital
Name [1] 289408 0
A+ Fund charity Hospital fund
Country [1] 289408 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
Private bag 92024
Auckland Mail Centre
1142
NZ
Country
New Zealand
Secondary sponsor category [1] 288091 0
None
Name [1] 288091 0
Address [1] 288091 0
Country [1] 288091 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291222 0
Health and disability Ethics Committees
Ethics committee address [1] 291222 0
Ethics committee country [1] 291222 0
New Zealand
Date submitted for ethics approval [1] 291222 0
29/07/2014
Approval date [1] 291222 0
Ethics approval number [1] 291222 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 94 94 0 0
/AnzctrAttachments/366530-220614_Fib-upfront PPH study protocol.docx

Contacts
Principal investigator
Name 49178 0
Dr Joreline van der Westhuizen
Address 49178 0
Level 8
Anaesthetic Department
Auckland City Hospital
2 Park Road
Grafton
1142
Auckland
Country 49178 0
New Zealand
Phone 49178 0
+64212456151
Fax 49178 0
Email 49178 0
jayv@adhb.govt.nz
Contact person for public queries
Name 49179 0
Joreline van der Westhuizen
Address 49179 0
Level 8
Anaesthetic Department
Auckland City Hospital
2 Park Road
Grafton
1142
Auckland
Country 49179 0
New Zealand
Phone 49179 0
+649 3074949
Fax 49179 0
Email 49179 0
jayv@adhb.govt.nz
Contact person for scientific queries
Name 49180 0
Joreline van der Westhuizen
Address 49180 0
Level 8
Anaesthetic Department
Auckland City Hospital
2 Park Road
Grafton
1142
Auckland
Country 49180 0
New Zealand
Phone 49180 0
+649 3074949
Fax 49180 0
Email 49180 0
jayv@adhb.govt.nz

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
No additional documents have been identified.