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Blood Loss, Surgical clinical trials

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NCT ID: NCT02557672 Completed - Bleeding Clinical Trials

PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding

Start date: August 2016
Phase: Phase 4
Study type: Interventional

This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and factor-mediated coagulopathy. Is there a difference in bleeding and transfusion requirements in patients received PCC versus FFP?

NCT ID: NCT02422056 Completed - Hemorrhage Clinical Trials

Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

Start date: December 2013
Phase: Phase 4
Study type: Interventional

Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding in palatoplasty.

NCT ID: NCT02364765 Completed - Surgical Blood Loss Clinical Trials

Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery

Start date: August 2010
Phase: N/A
Study type: Interventional

The purpose of the present study was to compare some hematologic parameters and operation time in patients who underwent esthetic bimaxillary surgery under hypotensive anesthesia.

NCT ID: NCT02359994 Completed - Clinical trials for Blood Loss, Surgical

Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System

CLOT
Start date: April 2015
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device. Three hundred and twenty four subjects across a maximum of 25 investigational sites undergoing open elective cardiac, general, or urological surgical procedures who meet the eligibility criteria will be intraoperatively randomized to receive no more than the entire contents of up to two 5 gram bellows of either the investigational device or a control hemostatic agent on a bleeding site, whose anatomic site is smaller than or equal to 25cm² and whose anatomic application site is smaller than or equal to 47cm², when bleeding is within the pre-defined bleeding severity range after any applicable conventional means for hemostasis are attempted as specified in the intraoperative procedures. Each investigational site is expected to enroll approximately 13-40 subjects. All investigational sites will be located in the U.S. Follow-up will occur at hospital discharge and 6 weeks post-device application. For oncologic subjects, an additional follow up will occur at 24 months post device application.

NCT ID: NCT02335359 Completed - Clinical trials for Blood Loss, Surgical

Tranexamic Acid in Major Vascular Surgery

Start date: March 4, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair

NCT ID: NCT02229292 Completed - Clinical trials for Intraoperative Bleeding

Prevention of Intraoperative Bleeding and Postoperative Swelling in Orthognathic Surgery Through the Use of Tranexamic Acid

TXA2014-15
Start date: August 19, 2014
Phase: Phase 4
Study type: Interventional

Purpose of the study: - To evaluate the effect of tranexamic acid (TXA) of intraoperative blood loss in patients subjected to bi-maxillary orthognathic surgery - To evaluate the potential effect of TXA on fibrin structure - To evaluate the potential effect of TXA of binding of plasminogen to fibrin - To evaluate the potential effect of TXA on postoperative edema formation. Hypothesis: H0: Intraoperative bleeding cannot be significantly reduced by preoperative administration of tranexamic acid H0,1: Postoperative edema cannot be significantly reduced by preoperative administration of tranexamic acid

NCT ID: NCT02043132 Completed - Clinical trials for Blood Loss, Surgical

Tranexamic Acid in Reverse Total Shoulder Arthroplasty

TXA
Start date: September 2013
Phase: Phase 2/Phase 3
Study type: Interventional

To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder arthroplasty.

NCT ID: NCT02013570 Completed - Clinical trials for Pain Postoperative, Intraoperative Hemorrhage

Efficacy of Peritonsillar Dexmedetomidine Infiltration for Postadenotonsillectomy Pain

Start date: September 2013
Phase: Phase 4
Study type: Interventional

The purpose of the present study is the clinical assessment of the efficacy of preincisional peritonsillar infiltration of dexmedetomidine on postoperative pain relief in children undergoing adenotonsillectomy.

NCT ID: NCT01891461 Completed - Clinical trials for Intraoperative Bleeding

Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR

Start date: January 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease intraoperative and immediate post-operative bleeding.

NCT ID: NCT01746628 Completed - Clinical trials for Operative Hemorrhage

Intrauterine Use of FloSeal: Is it Safe and Useful?

Start date: December 2012
Phase: N/A
Study type: Interventional

When having certain types of outpatient surgery inside the uterine cavity some women experience heavy bleeding. The only method presently available for controlling such bleeding, short of removing the uterus, involves the placement of a balloon pressure device inside the uterine cavity. The pressure along with the patient's own natural clotting ability will generally stop the bleeding. However, this treatment usually requires at least a 24 hour stay in the hospital. The investigators are researching the use of a compound (FloSeal) already approved for use in other areas of the human body, as a method of controlling bleeding. The use of FloSeal in the uterine cavity has not yet been tested and therefore is not yet an FDA approved indication for its safe use to control bleeding from the uterine cavity. In this study, The investigators want to find out what effect(s) FloSeal has on the uterine cavity. Twenty individuals will be included in this study at Northwest Hospital Center. All twenty individuals will be treated in the same fashion except ten of the participants will randomly be assigned to receive FloSeal and ten will not. Study participants are individuals currently scheduled to have a hysterectomy procedure, which involves surgically removing the uterus from the body for a previously determined standard of care treatment for a non- cancerous medical problem. Before performing the hysterectomy and evaluating the effects of FloSeal upon the tissues within the uterine cavity the following will be done. Once under anesthesia the uterine cavity will be subjected to a curettage (sharp scrapping) to produce a minor amount of bleeding from the lining of the uterus. Ten of the 20 study participants, randomly chosen, will then have FloSeal placed into their uterine cavity. The study participants will not know whether they received FloSeal or not. A balloon pressure device will then be placed into the uterine cavity of all 20 individuals and left in place for 5 minutes. After the allotted time, the balloon device will be removed. The hysterectomy will then be completed appropriately using standard methods and techniques. The uterus, once removed will be evaluated pathologically to determine the effects of the FloSeal upon the tissues of the cavity in those so treated and compared to the same analysis in those individuals who did not receive FloSeal. The pathologist will not know which patients received or did not receive FloSeal. This use of FloSeal is not currently an FDA approved use of the compound. The goal of this study is to obtain FDA approval for use in this situation.