Postpartum Haemorrhage
Conditions
Brief 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). 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).
Interventions
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fibrinogen level | At the time when the blood loss exceeds 1500 ml and 45 min later | Clauss method |
| Platelet function | At the time when the blood loss exceeds 1500 ml and 45 min later | PFA-100 |
| Clotting time (CT) | At the time when the blood loss exceeds 1500 ml and 45 min later | INTEM, EXTEM, FIBTEM and APTEM / ROTEM |
| Endogenous thrombin potential | At the time when the blood loss exceeds 1500 ml and 45 min later | CAT |
| Maximum clot firmness (MCF) | At the time when the blood loss exceeds 1500 ml and 45 min later | INTEM, EXTEM, FIBTEM and APTEM / ROTEM |
| Clot formation time (CFT) | At the time when the blood loss exceeds 1500 ml and 45 min later | INTEM, EXTEM, FIBTEM and APTEM / ROTEM |
Countries
Finland
Outcome results
None listed