Bleeding Clinical Trial
Official title:
A Controlled, Randomized, Multi-centre, Double Blind, Phase II Study to Evaluate Efficacy and Safety of Topical PeproStat in Intraoperative Surgical Haemostasis
The purpose of this study is to test the effectiveness and safety of a new peptide-based coagulant, PeproStat. The study drug will be applied to patients undergoing liver/soft tissue surgery, vascular surgery or spine surgery. The speed of action of the new coagulant, that is applied with a gelatin sponge, will be compared to the same sponge but with saline (a commonly used standard of care).
PeproStat is a new class of topical haemostatic agent composed of recombinant human albumin
(rHA) conjugated with fibrinogen-binding peptides. The conjugate polymerises fibrinogen into
a fibrin-like clot without the need for thrombin.
PeproStat is formulated in a liquid, and is soaked into a haemostatic gelatin sponge in the
operating theatre, and applied directly to the site of bleeding. The gelatin sponge
(Spongostan ) is an approved "passive" haemostat i.e., PeproStat is an adjunct to a passive
haemostat.
The study is designed in a 2:1 randomization (verum:placebo) to investigate the efficacy in
terms of Time to hemostasis, mean (mTTH) at the primary target bleed site (TBS), measured in
minutes (min) from the start of treatment application (TxStart) at the TBS to the achievement
of hemostasis at that site or to the end of the 10-minute assessment period if hemostasis has
not yet been achieved.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04058223 -
Comparison of the Short-term Outcomes of Using DST and PPH Staplers in the Treatment of Grade III and IV Hemorrhoids
|
||
| Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
| Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
| Completed |
NCT04590898 -
Peri-device Leakage Closure After LAAO
|
||
| Active, not recruiting |
NCT05563883 -
Atrial Fibrillation and Cancer: a Nationwide French Cohort Study
|
||
| Not yet recruiting |
NCT04537533 -
Tranexamic Acid Infusion in Low Dose Versus in High Dose for Reducing Blood Loss in Radical Cystectomy Operations
|
Phase 4 | |
| Withdrawn |
NCT02851940 -
Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids
|
N/A | |
| Completed |
NCT02722720 -
Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral
|
N/A | |
| Recruiting |
NCT02279186 -
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section
|
Phase 4 | |
| Active, not recruiting |
NCT02244853 -
Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease
|
N/A | |
| Completed |
NCT02980497 -
Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study
|
N/A | |
| Completed |
NCT02092415 -
Assessment of Limb Perfusion During Junctional Tourniquet
|
N/A | |
| Completed |
NCT02245854 -
Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps
|
N/A | |
| Not yet recruiting |
NCT01438736 -
Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?
|
Phase 4 | |
| Completed |
NCT00515541 -
Lovaza's Effect on the Activation of Platelets
|
Phase 2 | |
| Completed |
NCT00143715 -
Oral Vitamin K for Warfarin Associated Coagulopathy
|
Phase 3 | |
| Terminated |
NCT03954314 -
DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
|
Phase 3 | |
| Recruiting |
NCT05945680 -
Tranexamic Acid in Breast Esthetic Surgery.
|
Phase 4 | |
| Recruiting |
NCT03783182 -
Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy
|
Phase 4 | |
| Not yet recruiting |
NCT05464394 -
Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass
|
Phase 3 |