Clinical Trials Logo

Clinical 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). 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT01910675
Study type Interventional
Source Helsinki University Central Hospital
Contact
Status Withdrawn
Phase Phase 4
Start date July 2013
Completion date October 2018

See also
  Status Clinical Trial Phase
Completed NCT02509351 - Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section? Phase 2/Phase 3
Completed NCT01931423 - The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study N/A
Completed NCT00499005 - Carbetocin Versus Syntometrine for the Third Stage of Labour Phase 4
Completed NCT01485562 - Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births N/A
Completed NCT01359878 - Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial Phase 2/Phase 3
Completed NCT00872469 - World Maternal Antifibrinolytic Trial Phase 3
Completed NCT02704780 - Two Different Regimens of Misoprostol in Retained Placenta Phase 2
Not yet recruiting NCT02396303 - Carbetocin Versus Oxytocin in Caesarean Section for the Control of Postpartum Haemorrhage Phase 0
Completed NCT01931410 - The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial Phase 4
Completed NCT01895218 - Treatment of Women After Postpartum Haemorrhage Phase 3
Recruiting NCT02187874 - Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early. N/A
Completed NCT02562300 - Uterotonics Using to Reduce Bleeding at Cesarean Section Phase 2
Completed NCT01044082 - Prevention of Post-partum Haemorrhage N/A
Completed NCT01116050 - Intrarectal Misoprostol in Postpartum Haemorrhage Phase 3
Completed NCT02149472 - Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage
Recruiting NCT02492087 - Topical Tranexamic Acid in Caesarean Section Phase 3
Completed NCT02468310 - Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana N/A
Recruiting NCT02136719 - Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery N/A