The FIB-PPH trial: fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial

Trials

Volumn 13, Issue , 2012, Pages

  Wikkelsoe, Anne J ^a   Afshari, Arash ^b,c   Stensballe, Jakob ^b   Langhoff Roos, Jens ^b   Albrechtsen, Charlotte ^b   Ekelund, Kim ^b   Hanke, Gabriele ^b   Sharif, Heidi F ^b   Mitchell, Anja U ^a   Svare, Jens ^a   Troelstrup, Ane ^a   Pedersen, Lars M ^a   Lauenborg, Jeannet ^a   Madsen, Mette G ^a   Bødker, Birgit ^a   Møller, Ann M ^a  

^a Mental Health Services CPH   (Denmark)

^b Rigshospitalet   (Denmark)

^c GENEVA UNIVERSITY HOSPITALS   (Switzerland)

Author keywords

Blood transfusion; Coagulation; Fibrinogen concentrate; Haemostasis; Obstetrics; Postpartum haemorrhage; Thrombelastography

Indexed keywords

FIBRINOGEN CONCENTRATE;

ARTICLE; BLOOD TRANSFUSION; CLINICAL PROTOCOL; DENMARK; FOLLOW UP; HUMAN; MULTICENTER STUDY (TOPIC); POSTPARTUM HEMORRHAGE; RANDOMIZED CONTROLLED TRIAL (TOPIC); STUDY DESIGN; THROMBOELASTOGRAPHY;

BLOOD COAGULATION TESTS; BLOOD TRANSFUSION; DENMARK; DOUBLE-BLIND METHOD; FEMALE; FIBRINOGEN; HEMOSTATICS; HUMANS; POSTPARTUM HEMORRHAGE; PREDICTIVE VALUE OF TESTS; PREGNANCY; RESEARCH DESIGN; THROMBELASTOGRAPHY; TIME FACTORS; TREATMENT OUTCOME;

EID: 84865854879     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-110     Document Type: Article

References (55)

1. Johansson PI, Ostrowski SR, Secher NH. Management of major blood loss: an update. Acta Anaesthesiol Scand 2010, 54:1039-1049. 10.1111/j.1399-6576.2010.02265.x, 20626354.
2. Paidas MJ, Hossain N, Shamsi TS, Rodger MA, Langhoff-Roos J, Lockwood CJ. Hemostasis and Thrombosis in Obstetrics & Gynecology 2011, Wiley-Blackwell, Oxford.
3. Bonnar J. Massive obstetric haemorrhage. Baillieres Best Pract Res Clin Obstet Gynaecol 2000, 14:1-18. 10.1053/beog.1999.0060, 10789257.
4. Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol 2008, 22:999-1012. 10.1016/j.bpobgyn.2008.08.004, 18819848.
5. Mousa HA, Alfirevic Z. Treatment for primary postpartum haemorrhage. Cochrane Database Syst Rev 2007, CD003249.
6. Hiippala ST, Myllyla GJ, Vahtera EM. Hemostatic factors and replacement of major blood loss with plasma-poor red cell concentrates. Anesth Analg 1995, 81:360-365.
7. Charbit B, Mandelbrot L, Samain E, Baron G, Haddaoui B, Keita H, Sibony O, Mahieu-Caputo D, Hurtaud-Roux MF, Huisse MG, Denninger MH, de Prost D, . PPH Study Group The decrease of fibrinogen is an early predictor of the severity of postpartum hemorrhage. J Thromb Haemost 2007, 5:266-273. 10.1111/j.1538-7836.2007.02297.x, 17087729, PPH Study Group.
8. Fenger-Eriksen C, Lindberg-Larsen M, Christensen AQ, Ingerslev J, Sorensen B. Fibrinogen concentrate substitution therapy in patients with massive haemorrhage and low plasma fibrinogen concentrations. Br J Anaesth 2008, 101:769-773. 10.1093/bja/aen270, 18818192.
9. Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG 2009, 116:1097-1102. 10.1111/j.1471-0528.2009.02187.x, 19459866.
10. Fenger-Eriksen C, Ingerslev J, Sorensen B. Fibrinogen concentrate-a potential universal hemostatic agent. Expert Opin Biol Ther 2009, 9:1325-1333. 10.1517/14712590903193051, 19645632.
11. Huissoud C, Carrabin N, Benchaib M, Fontaine O, Levrat A, Massignon D, Touzet S, Rudigoz RC, Berland M. Coagulation assessment by rotation thrombelastometry in normal pregnancy. Thromb Haemost 2009, 101:755-761.
12. Blome M, Isgro F, Kiessling AH, Skuras J, Haubelt H, Hellstern P, Saggau W. Relationship between factor XIII activity, fibrinogen, haemostasis screening tests and postoperative bleeding in cardiopulmonary bypass surgery. Thromb Haemost 2005, 93:1101-1107.
13. Gerlach R, Tolle F, Raabe A, Zimmermann M, Siegemund A, Seifert V. Increased risk for postoperative hemorrhage after intracranial surgery in patients with decreased factor XIII activity: implications of a prospective study. Stroke 2002, 33:1618-1623. 10.1161/01.STR.0000017219.83330.FF, 12053001.
14. Parasnis H, Raje B, Hinduja IN. Relevance of plasma fibrinogen estimation in obstetric complications. J Postgrad Med 1992, 38:183-185.
15. Rahe-Meyer N, Solomon C, Winterhalter M, Piepenbrock S, Tanaka K, Haverich A, Pichlmaier M. Thromboelastometry-guided administration of fibrinogen concentrate for the treatment of excessive intraoperative bleeding in thoracoabdominal aortic aneurysm surgery. J Thorac Cardiovasc Surg 2009, 138:694-702. 10.1016/j.jtcvs.2008.11.065, 19698858.
16. Stinger HK, Spinella PC, Perkins JG, Grathwohl KW, Salinas J, Martini WZ, Hess JR, Dubick MA, Simon CD, Beekley AC, Wolf SE, Wade CE, Holcomb JB. The ratio of fibrinogen to red cells transfused affects survival in casualties receiving massive transfusions at an army combat support hospital. J Trauma 2008, 64:S79-S85. 10.1097/TA.0b013e318160a57b, 18376176.
17. Ucar HI, Oc M, Tok M, Dogan OF, Oc B, Aydin A, Farsak B, Guvener M, Yorgancioglu AC, Dogan R, Demircin M, Pasaoglu I. Preoperative fibrinogen levels as a predictor of postoperative bleeding after open heart surgery. Heart Surg Forum 2007, 10:E392-E396. 10.1532/HSF98.20071065, 17855205.
18. Weinkove R, Rangarajan S. Fibrinogen concentrate for acquired hypofibrinogenaemic states. Transfus Med 2008, 18:151-157. 10.1111/j.1365-3148.2008.00854.x, 18598277.
19. Practice guidelines for perioperative blood transfusion and adjuvant therapies: an updated report by the American Society of Anesthesiologists Task Force on perioperative blood transfusion and adjuvant therapies. Anesthesiology 2006, 105:198-208. 10.1097/00000542-200607000-00030, 16810012.
20. Searle E, Pavord S, Alfirevic Z. Recombinant factor VIIa and other pro-haemostatic therapies in primary postpartum haemorrhage. Best Pract Res Clin Obstet Gynaecol 2008, 22:1075-1088. 10.1016/j.bpobgyn.2008.08.010, 18838340.
21. Theusinger OM, Spahn DR, Ganter MT. Transfusion in trauma: why and how should we change our current practice?. Curr Opin Anaesthesiol 2009, 22:305-312. 10.1097/ACO.0b013e3283212c7c, 19390257.
22. Kreuz W, Meili E, Peter-Salonen K, Dobrkovska A, Devay J, Haertel S, Krzensk U, Egbring R. Pharmacokinetic properties of a pasteurised fibrinogen concentrate. Transfus Apher Sci 2005, 32:239-246. 10.1016/j.transci.2004.04.003, 15919241.
23. Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg 2009, 108:759-769. 10.1213/ane.0b013e3181930a6e, 19224780.
24. Rahe-Meyer N, Sorensen B. For: Fibrinogen concentrate for management of bleeding. J Thromb Haemost 2011, 9:1-5.
25. Fenger-Eriksen C, Jensen TM, Kristensen BS, Jensen KM, Tonnesen E, Ingerslev J, Sorensen B. Fibrinogen substitution improves whole blood clot firmness after dilution with hydroxyethyl starch in bleeding patients undergoing radical cystectomy: a randomized, placebo-controlled clinical trial. J Thromb Haemost 2009, 7:795-802. 10.1111/j.1538-7836.2009.03331.x, 19320829.
26. Karlsson M, Ternstrom L, Hyllner M, Baghaei F, Flinck A, Skrtic S, Jeppsson A. Prophylactic fibrinogen infusion reduces bleeding after coronary artery bypass surgery. A prospective randomised pilot study. Thromb Haemost 2009, 102:137-144.
27. Cui Y, Hei F, Long C, Feng Z, Zhao J, Yan F, Wang Y, Liu J. Perioperative monitoring of thromboelastograph on blood protection and recovery for severely cyanotic patients undergoing complex cardiac surgery. Artif Organs 2010, 34:955-960. 10.1111/j.1525-1594.2010.01148.x, 21092037.
28. Lang T, Bauters A, Braun SL, Potzsch B, von Pape KW, Kolde HJ, Lakner M. Multi-centre investigation on reference ranges for ROTEM thromboelastometry. Blood Coagul Fibrinolysis 2005, 16:301-310. 10.1097/01.mbc.0000169225.31173.19, 15870552.
29. Thorarinsdottir HR, Sigurbjornsson FT, Hreinsson K, Onundarson PT, Gudbjartsson T, Sigurdsson GH. Effects of fibrinogen concentrate administration during severe hemorrhage. Acta Anaesthesiol Scand 2010, 54:1077-1082. 10.1111/j.1399-6576.2010.02289.x, 20887409.
30. Ducloy-Bouthors AS, Broisin F, Teboul C, Jaffry A, Waegemans T, Padrazzi B, Ducloy-Bouthors AS, Broisin F, Teboul C, Jaffry A, Waegemans T, Padrazzi B. A multicenter prospective open-label study assessing efficacy and safety of a triple-secured fibrinogen concentrate in the treatment of postpartum haemorrhage 2008, Brussels, Belgium.
31. Danes AF, Cuenca LG, Bueno SR, Mendarte BL, Ronsano JB. Efficacy and tolerability of human fibrinogen concentrate administration to patients with acquired fibrinogen deficiency and active or in high-risk severe bleeding. Vox Sang 2008, 94:221-226. 10.1111/j.1423-0410.2007.01024.x, 18179679.
32. Chauleur C, Cochery-Nouvellon E, Mercier E, Aya G, Mares P, Mismetti P, Lissalde-Lavigne G, Gris JC. Analysis of the venous thromboembolic risk associated with severe postpartum haemorrhage in the NOHA First cohort. Thromb Haemost 2008, 100:773-779.
33. Guasch E, Alsina E, Diez J, Ruiz R, Gilsanz F. Postpartum hemorrhage: an observational study of 21,726 deliveries in 28 months. Rev Esp Anestesiol Reanim 2009, 56:139-146.
34. Bell SF, Rayment R, Collins PW, Collis RE. The use of fibrinogen concentrate to correct hypofibrinogenaemia rapidly during obstetric haemorrhage. Int J Obstet Anesth 2010, 19:218-223. 10.1016/j.ijoa.2009.08.004, 20194010.
35. Dickneite G, Pragst I, Joch C, Bergman GE. Animal model and clinical evidence indicating low thrombogenic potential of fibrinogen concentrate (Haemocomplettan P). Blood Coagul Fibrinolysis 2009, 20:535-540. 10.1097/MBC.0b013e32832da1c5, 19710609.
36. Koch CG, Li L, Duncan AI, Mihaljevic T, Cosgrove DM, Loop FD, Starr NJ, Blackstone EH. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Crit Care Med 2006, 34:1608-1616. 10.1097/01.CCM.0000217920.48559.D8, 16607235.
37. Koch CG, Li L, Duncan AI, Mihaljevic T, Loop FD, Starr NJ, Blackstone EH. Transfusion in coronary artery bypass grafting is associated with reduced long-term survival. Ann Thorac Surg 2006, 81:1650-1657. 10.1016/j.athoracsur.2005.12.037, 16631651.
38. Utter GH, Lee TH, Rivers RM, Montalvo L, Wen L, Chafets DM, Reed WF, Busch MP. Microchimerism decades after transfusion among combat-injured US veterans from the Vietnam, Korean, and World War II conflicts. Transfusion 2008, 48:1609-1615. 10.1111/j.1537-2995.2008.01758.x, 18503616.
39. Utter GH, Reed WF, Lee TH, Busch MP. Transfusion-associated microchimerism. Vox Sang 2007, 93:188-195. 10.1111/j.1423-0410.2007.00954.x, 17845255.
40. CSL Behring summary of product characteristics 2012, http://www.riastap.com/docs/RiaSTAP_PI.pdf.
41. Bais JM, Eskes M, Pel M, Bonsel GJ, Bleker OP. Postpartum haemorrhage in nulliparous women: incidence and risk factors in low and high risk women. A Dutch population-based cohort study on standard (> or = 500 ml) and severe (> or = 1000 ml) postpartum haemorrhage. Eur J Obstet Gynecol Reprod Biol 2004, 115:166-172.
42. Balki M, Dhumne S, Kasodekar S, Seaward G, Carvalho JC. Blood transfusion for primary postpartum hemorrhage: a tertiary care hospital review. J Obstet Gynaecol Can 2008, 30:1002-1007.
43. James AH, Paglia MJ, Gernsheimer T, Grotegut C, Thames B. Blood component therapy in postpartum hemorrhage. Transfusion 2009, 49:2430-2433. 10.1111/j.1537-2995.2009.02318.x, 19624606.
44. Jansen AJ, van Rhenen DJ, Steegers EA, Duvekot JJ. Postpartum hemorrhage and transfusion of blood and blood components. Obstet Gynecol Surv 2005, 60:663-671. 10.1097/01.ogx.0000180909.31293.cf, 16186783.
45. Fenger-Eriksen C, Tonnesen E, Ingerslev J, Sorensen B. Mechanisms of hydroxyethyl starch induced dilutional coagulopathy. J Thromb Haemost 2009, 7:1099-1105. 10.1111/j.1538-7836.2009.03460.x, 19422451.
46. Harmonised ICH. Tripartite Guideline. Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group. Stat Med 1999, 18:1905-1942.
47. Schafer JL. Multiple imputation: a primer. Stat Methods Med Res 1999, 8:3-15. 10.1191/096228099671525676, 10347857.
48. McLintock C. Obstetric haemorrhage. Thromb Res 2009, Suppl 2:S30-S34.
49. Holm C, Langhoff-Roos J, Petersen KB, Norgaard A, Diness BR. Severe post partum haemorrhage and mode of delivery: a retrospective cohort study. BJOG 2012, in press.
50. Dzik WH, Blajchman MA, Fergusson D, Hameed M, Henry B, Kirkpatrick AW, Korogyi T, Logsetty S, Skeate RC, Stanworth S, Macadams C, Muirhead B. Clinical review: Canadian National Advisory Committee on Blood and Blood Products - Massive Transfusion Consensus Conference 2011: report of the panel. Crit Care 2011, 15:242. 10.1186/cc10498, 22188866.
51. Kozek-Langenecker S, Sorensen B, Hess JR, Spahn DR. Clinical effectiveness of fresh frozen plasma compared with fibrinogen concentrate: a systematic review. Crit Care 2011, 15:R239. 10.1186/cc10488, 3334790, 21999308.
52. Meyer MA, Ostrowski SR, Windelov NA, Johansson PI. Fibrinogen concentrates for bleeding trauma patients: what is the evidence?. Vox Sang 2011, 101:185-190. 10.1111/j.1423-0410.2011.01478.x, 21535437.
53. Warmuth M, Mad P, Wild C. Systematic review of the efficacy and safety of fibrinogen concentrate substitution in adults. Acta Anaesthesiol Scand 2012, 56:539-48. Epub 2011 Dec 12, 10.1111/j.1399-6576.2011.02586.x, 22150561.
54. Ozier Y, Hunt BJ. Against: Fibrinogen concentrate for management of bleeding: against indiscriminate use. J Thromb Haemost 2011, 9:6-8. 10.1111/j.1538-7836.2010.04083.x, 21210948.
55. Shakur H, Elbourne D, Gulmezoglu M, Alfirevic Z, Ronsmans C, Allen E, Roberts I. The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial. Trials 2010, 11:40. 10.1186/1745-6215-11-40, 2864262, 20398351.