Postpartum HaemorrhagePhase 4NCT01910675
PCC and Fibrinogen Compared With FFP in PPH
A Phase 4 study testing PCC and FFP in people with Postpartum Haemorrhage, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of the study is to find out if the regimen of prothrombin complex concentrate (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum haemorrhage (PPH). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Haemorrhage
- What is being tested?
- PCC and FFP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- Jul 2013to Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who have delivered vaginally or by caesarean section with a PPH of 2000 ml (the amount of blood loss: in addition to the suctioned blood, sponges, wraps, swabs, etc. are carefully weighed)
Who cannot join
- Women with a history of bleeding tendency or hepatic or renal insufficiency, or PPH exceeding 3000 ml because in that case the initial need for fibrinogen may be even more
Trial locations and contacts
1 site in 1 country.
Finland1 site
Maternity Hospital, Helsinki University Central Hospital
Helsinki, Uusimaa, FI-00610
About this study
Official title: Use of Prothrombin Complex Concentrate and Fibrinogen Compared With Fresh Frozen Plasma (and Fibrinogen if Needed) in the Treatment of Postpartum Haemorrhage
The purpose of the study is to find out if the regimen of prothrombin complex concentrate (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum haemorrhage (PPH). The original protocol included the use of HES and the recruitment of patients was postponed while waiting the final decision by EMA. All HES solutions were abandoned at our institution in September and an amendment was made to change the protocol. HES solution are replaced by the use of hyperoncotic (20%) albumin.
Read the detailed description
Forty patients are randomized to receive either PCC and fibrinogen concentrate (PCC group) or FFP (and fibrinogen if needed) (FFP group), 20 patients in each group. Patients in the PCC group receive 15 IU/kg of PCC concentrate and 2 g of fibrinogen concentrate. Patients in the FFP group receive 4 units of FFP. In both groups, additional fibrinogen is administered (if needed) to increase the baseline FIBTEM-MCF (at 5 min) to the target of 15 mm.
Baseline blood samples will be drawn at study inclusion when the (on-going) blood loss exceeds 1500 ml. The next samples will be drawn at 45 min (or immediately after the administration of the study drug if later). Otherwise, the management protocol strictly follows the local PPH guideline.
The primary endpoint is the amount of blood loss within the first 6 and 24 hours after delivery. Secondary endpoints include the difference/similarity in the laboratory determinations (ia coagulation screen, PFA-100, CAT and ROTEM).
- Conditions
- Postpartum Haemorrhage
- Being tested
- PCC, FFP
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCCDrug
Also called Octaplex, Riastab
15 IU/kg Octaplex and 2 g Riastab. Additional fibrinogen if needed.
FFPDrug
Also called Octaplas
4 units Octaplas. Additional fibrinogen if needed.
| Study group | Role | What they receive |
|---|---|---|
| PCC group | Experimental | Twenty patients in the PCC group receive 15 IU/kg of Octaplex concentrate and 2 g of Riastap concentrate. Additional fibrinogen is administered (if needed) to increase the baseline FIBTEM-MCF (at 5 min) to the target of 15 mm. Receives: Drug: PCC |
| FFP group | Active comparator | Twenty patients in the FFP group receive 4 units of FFP (Octaplas). Additional fibrinogen (Riastab) is administered (if needed) to increase the baseline FIBTEM-MCF (at 5 min) to the target of 15 mm. The fibrinogen content of the FFP will be taken into consideration (2.1 g in 4 units of FFP). Receives: Drug: FFP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
The suctioned blood is recorded and sponges, wraps, swabs, etc. are carefully weighed. The amount of blood loss will be compared between the groups.
Measured: Within the first 6 and 24 hours after delivery
Secondary outcomes (6)
Maximum clot firmness (MCF)
INTEM, EXTEM, FIBTEM and APTEM / ROTEM
Measured: At the time when the blood loss exceeds 1500 ml and 45 min later
Endogenous thrombin potential
CAT
Measured: At the time when the blood loss exceeds 1500 ml and 45 min later
Fibrinogen level
Clauss method
Measured: At the time when the blood loss exceeds 1500 ml and 45 min later
Platelet function
PFA-100
Measured: At the time when the blood loss exceeds 1500 ml and 45 min later
Clotting time (CT)
INTEM, EXTEM, FIBTEM and APTEM / ROTEM
Measured: At the time when the blood loss exceeds 1500 ml and 45 min later
Clot formation time (CFT)
INTEM, EXTEM, FIBTEM and APTEM / ROTEM
Measured: At the time when the blood loss exceeds 1500 ml and 45 min later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Why it stopped: Impossible to get a written informed consent beforehand
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HaemorrhageStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jouni Ahonen, Helsinki University Central Hospital
- Investigators
- Jouni V. Ahonen, Ph.D., M.D., Principal investigator, Maternity Hospital, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910675
- Sponsor's protocol ID
- EudraCT-2012-003128
- Other IDs
- U1030N7560
- Status last verified
- Oct 2018
- First submitted
- 13 Jul 2013
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ahonen J, Stefanovic V, Lassila R. Management of post-partum haemorrhage. Acta Anaesthesiol Scand. 2010 Nov;54(10):1164-78. doi: 10.1111/j.1399-6576.2010.02309.x.
PubMed 21069897
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Prothrombin Complex Concentrate and Fibrinogen Compared With Fresh Frozen Plasma (and Fibrinogen if Needed) in the Treatment of Postpartum Haemorrhage
- ClinicalTrials.gov ID
- NCT01910675
- Acronym / sponsor ID
- EudraCT-2012-003128
- Conditions
- Postpartum Haemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Impossible to get a written informed consent beforehand
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to find out if the regimen of prothrombin complex concentrate (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum haemorrhage (PPH). The original protocol included the use of HES and the recruitment of patients was postponed while waiting the final decision by EMA. All HES solutions were abandoned at our institution in September and an amendment was made to change the protocol. HES solution are replaced by the use of hyperoncotic (20%) albumin.
Detailed description
Forty patients are randomized to receive either PCC and fibrinogen concentrate (PCC group) or FFP (and fibrinogen if needed) (FFP group), 20 patients in each group. Patients in the PCC group receive 15 IU/kg of PCC concentrate and 2 g of fibrinogen concentrate. Patients in the FFP group receive 4 units of FFP. In both groups, additional fibrinogen is administered (if needed) to increase the baseline FIBTEM-MCF (at 5 min) to the target of 15 mm.
Baseline blood samples will be drawn at study inclusion when the (on-going) blood loss exceeds 1500 ml. The next samples will be drawn at 45 min (or immediately after the administration of the study drug if later). Otherwise, the management protocol strictly follows the local PPH guideline.
The primary endpoint is the amount of blood loss within the first 6 and 24 hours after delivery. Secondary endpoints include the difference/similarity in the laboratory determinations (ia coagulation screen, PFA-100, CAT and ROTEM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCC group | Experimental | Drug: PCCTwenty patients in the PCC group receive 15 IU/kg of Octaplex concentrate and 2 g of Riastap concentrate. Additional fibrinogen is administered (if needed) to increase the baseline FIBTEM-MCF (at 5 min) to the target of 15 mm. |
| FFP group | Active comparator | Drug: FFPTwenty patients in the FFP group receive 4 units of FFP (Octaplas). Additional fibrinogen (Riastab) is administered (if needed) to increase the baseline FIBTEM-MCF (at 5 min) to the target of 15 mm. The fibrinogen content of the FFP will be taken into consideration (2.1 g in 4 units of FFP). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who have delivered vaginally or by caesarean section with a PPH of 2000 ml (the amount of blood loss: in addition to the suctioned blood, sponges, wraps, swabs, etc. are carefully weighed)
Key exclusion criteria (1 listed)
- Women with a history of bleeding tendency or hepatic or renal insufficiency, or PPH exceeding 3000 ml because in that case the initial need for fibrinogen may be even more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCCAlso: Octaplex, Riastab15 IU/kg Octaplex and 2 g Riastab. Additional fibrinogen if needed. | Drug | PCC group |
| FFPAlso: Octaplas4 units Octaplas. Additional fibrinogen if needed. | Drug | FFP group |
Primary outcome
Blood loss
Time frame: Within the first 6 and 24 hours after delivery
The suctioned blood is recorded and sponges, wraps, swabs, etc. are carefully weighed. The amount of blood loss will be compared between the groups.
6 secondary outcomes
Maximum clot firmness (MCF)
Time frame: At the time when the blood loss exceeds 1500 ml and 45 min later
Endogenous thrombin potential
Time frame: At the time when the blood loss exceeds 1500 ml and 45 min later
Fibrinogen level
Time frame: At the time when the blood loss exceeds 1500 ml and 45 min later
Platelet function
Time frame: At the time when the blood loss exceeds 1500 ml and 45 min later
Clotting time (CT)
Time frame: At the time when the blood loss exceeds 1500 ml and 45 min later
Clot formation time (CFT)
Time frame: At the time when the blood loss exceeds 1500 ml and 45 min later
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Background: PubMed 21069897Ahonen J, Stefanovic V, Lassila R. Management of post-partum haemorrhage. Acta Anaesthesiol Scand. 2010 Nov;54(10):1164-78. doi: 10.1111/j.1399-6576.2010.02309.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jouni V. Ahonen, Ph.D., M.D. principal investigator
Maternity Hospital, Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCC and FFP in people with Postpartum Haemorrhage, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: Within the first 6 and 24 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01910675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.