Clinical trials: Surgical Bleeding
- Condition Surgical Bleeding
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery
The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery.
- Trial name
- NCT01127477
- Testing
- 1: Hydroxyethyl starch 130/0.4, 6 %
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Fresenius Kabi Japan
Surgical Bleeding
Safety and Efficacy of WoundClot Surgical
The goal of this clinical trial is to verify that WoundClot Surgical helps stop bleedings which may occur during surgery. It will also help learn more about the safety of WoundClot Surgical.
- Trial name
- WCS-1 (NCT06696092)
- Testing
- Hemostatic Agent
- Where
- 8 sites in Romania
- Volunteers
- 72 people
- Sponsor
- Core Scientific Creations Ltd.
Oral Hemorrhage
Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental…
- Trial name
- NCT05171231
- Testing
- HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD
- Where
- 10 sites in Belgium, France
- Volunteers
- 125 people
- Sponsor
- Septodont
Antithrombin III Deficiency
Safety, Pharmacokinetics and Efficacy of an ATIII Concentrate
To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.
- Trial name
- NCT00319228
- Testing
- Plasma-derived AT-III concentrate
- Volunteers
- 3 people
- Sponsor
- Instituto Grifols, S.A.
Congenital Fibrinogen Deficiency
An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency.
- Trial name
- NCT02427217
- Testing
- FCH
- Where
- 11 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- CSL Behring
Intra-operative Bleeding
Oxidized Cellulose hEmostAsis evaluatioN
The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to…
- Trial name
- OCEAN (NCT01637025)
- Testing
- Oxidized cellulose strip, Oxidized regenerated cellulose strip
- Where
- 24 sites in Czechia, Germany and 2 more
- Volunteers
- 111 people
- Sponsor
- Baxter Healthcare Corporation
Acquired Bleeding Disorder, Bleeding During/Following Surgery
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic stem…
- Trial name
- NCT01564563
- Testing
- standard therapy, activated recombinant human factor VII
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Novo Nordisk A/S
Blood Loss, Surgical
Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery
A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
- Trial name
- NCT00307515
- Testing
- Fibrin Sealant 2 (FS2), Oxidized Regenerated Cellulose (Surgicel)
- Where
- 16 sites in United States
- Volunteers
- 135 people
- Sponsor
- Ethicon, Inc.
Hemophilia A
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion…
- Trial name
- NCT00243659
- Testing
- ReFacto AF
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 30 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Congenital Fibrinogen Deficiency
Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.
- Trial name
- NCT02267226
- Testing
- Octafibrin
- Where
- 12 sites in United States, Bulgaria and 7 more
- Volunteers
- 25 people
- Sponsor
- Octapharma
Congenital Bleeding Disorder, Haemophilia A
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8))…
- Trial name
- guardian™1 (NCT00840086)
- Testing
- turoctocog alfa
- Where
- 63 sites in United States, Brazil and 16 more
- Volunteers
- 150 people
- Sponsor
- Novo Nordisk A/S
Von Willebrand Disease
Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients
To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures.
- Trial name
- NCT00555555
- Testing
- Alphanate SD/HT
- Volunteers
- 4 people
- Sponsor
- Grifols Biologicals, LLC
Coagulation Protein Disorders, Blood Loss, Surgical
Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation).
- Conditions
- Coagulation Protein Disorders, Blood Loss, Surgical, Perioperative Care
- Trial name
- NCT01053169
- Testing
- Beriplex® P/N, Fresh Frozen Plasma (FFP) and Beriplex® P/N, Fresh Frozen Plasma
- Where
- 6 sites in United Kingdom
- Volunteers
- 445 people
- Sponsor
- CSL Behring
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery
This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01561391
- Testing
- activated recombinant human factor VII, factor IX, factor VIII
- Where
- 14 sites in United States
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
Excessive Bleeding During Surgery
A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants
The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment…
- Trial name
- NCT03461406
- Testing
- Fibrin Sealant Grifols, EVICEL
- Where
- 40 sites in United States, Bulgaria and 8 more
- Volunteers
- 186 people
- Sponsor
- Instituto Grifols, S.A.
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors
This study is conducted in the United States of America (USA). The aim of this study is to assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic surgery (EOS) patients from previously reported…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01830712
- Testing
- eptacog alfa (activated)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Novo Nordisk A/S
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Hemorrhage, Soft Tissue Bleeding
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
- Trial name
- NCT02227706
- Testing
- EVICEL® Fibrin Sealant, SURGICEL® Absorbable Hemostat
- Where
- 13 sites in Belgium, Canada and 1 more
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Surgical Hemostasis
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.
- Trial name
- NCT00371215
- Testing
- rThrombin
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- ZymoGenetics
Target Bleeding Site During Peripheral Vascular Surgery
Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis
The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.
- Trial name
- NCT00684047
- Testing
- FS Grifols, Manual Compression
- Where
- 19 sites in Canada, Spain and 1 more
- Volunteers
- 239 people
- Sponsor
- Instituto Grifols, S.A.