Hematoma Clinical Trials – Open

1 Recruiting Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer 

Conditions: Breast Cancer;   Pain;   Perioperative/Postoperative Complications
Intervention: Procedure: therapeutic conventional surgery
Sponsors: University of California, Davis;   National Cancer Institute (NCI)
Gender: Female
Age Groups: Adult / Senior
Phase:
Number Enrolled: 74
Funded By: Other / NIH
Study Type: Observational
Study Design:
NCT ID: NCT00859157
Other IDs: CDR0000633754,   UCD-CCSO001,   200816282-1
First Received Date: March 7, 2009
Start Date: October 2008
Completion Date:
Last Verified Date: December 2009
Acronym:
Primary Completion Date: October 2010
Outcome Measures: Post-operative pain at 1 and at 7-10 days after mastectomy;   Number of acetaminophen/oxycodone tablets taken;   Total time of operation from breast incision to completion of wound closure;   Time of operation from first incision to completion of both superior and inferior skin flaps;   Estimated blood loss;   Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours;   Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively



2 Not yet recruiting Comparing the Outcome of Two Intraoperative Analgesia Techniques After Hepato-pancreato-biliary Surgery 

Conditions: Pain;   Analgesia;   Sedation
Interventions: Drug: Intrathecal morphine;   Drug: Continuous IV remifentanil
Sponsor: Tel-Aviv Sourasky Medical Center
Gender: Both
Age Groups: Adult / Senior
Phase:
Number Enrolled: 140
Funded By: Other
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID: NCT01201499
Other IDs: TASMC-10-IM-0073-CTIL
First Received Date: September 13, 2010
Start Date: November 2010
Completion Date: January 2012
Last Verified Date: September 2010
Acronym:
Primary Completion Date: November 2011
Outcome Measures: postoperative pain;   Recovery and adverse effects
3 Recruiting Prophylaxis Against DVTs After Primary Hip and Knee Replacement Surgery 

Condition: Pulmonary Embolism
Interventions: Drug: warfarin;   Drug: Fondaparinux:
Sponsor: The New England Baptist Hospital
Gender: Both
Age Groups: Adult / Senior
Phase:
Number Enrolled: 330
Funded By: Other
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
NCT ID: NCT00767559
Other IDs: NEBH 2008-016
First Received Date: October 3, 2008
Start Date: November 2008
Completion Date: May 2012
Last Verified Date: November 2010
Acronym: DVT
Primary Completion Date: May 2011
Outcome Measures: Primary Outcome based upon intent to treat: Composite outcome of;   Ultrasound or venogram confirmed deep vein thrombosis.;   Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus.;   Death due to TED;   Patient compliance with preoperative and post-operative medication schedule. Not enough space to note all measures;   Distribution of proximal vs distal deep vein thrombosis of the leg;   Amount of intraoperative bleeding;   Amount of postoperative bleeding A. transfusion requirement B. Hematomas requiring intervention, or other bleed clinically thought to be related to study drug. C. Other hemorrhagic events.;   Number of ultrasounds and V/Q or CTA’s required;   Costs associated with each study arm, including that of drug, laboratory monitors, radiology procedures required, lengths of stay, and management of complications;   Determine if negative D-D dimer can eliminate need for ultrasound analysis at follow-up visit.;   Death due to any other cause than TED;   Use of low molecular weight dextran;   Use of nonsteroidal anti-inflammatory drugs
4 Recruiting Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT 

Conditions: Venous Insufficiency;   Varicose Veins
Interventions: Procedure: Surgery;   Procedure: EVLT
Sponsors: University of Hull;   Hull and East Yorkshire Hospitals NHS Trust
Gender: Both
Age Groups: Adult / Senior
Phase:
Number Enrolled: 106
Funded By: Other
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID: NCT00841178
Other IDs: EVLT 2
First Received Date: February 10, 2009
Start Date: October 2005
Completion Date:
Last Verified Date: January 2010
Acronym:
Primary Completion Date: August 2010
Outcome Measures: Generic Quality of Life – Short Form-36;   Disease Specific Quality of Life – Aberdeen Varicose Vein Questionnaire;   Generic quality of life – EuroQol;   Venous Clinical Severity Score;   Visual analogue pain scores;   Return to work and normal functioning;   Would undergo EVLT again if necessary;   Complication rates;   Duplex assessment;   Cost Effectiveness
5 Recruiting Chronic Subdural Hematoma – Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors 

Condition: Hematoma, Subdural, Chronic
Interventions: Drug: Perindopril;   Drug: Placebo
Sponsors: Odense University Hospital;   Alice Brenaa Foundation;   Hede Nielsen Foundation;   Overlægerådets legatudvalg;   Good Clinical Practice Unit at Odense University Hospital;   University of Southern Denmark
Gender: Both
Age Groups: Adult / Senior
Phase:
Number Enrolled: 120
Funded By: Other
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID: NCT00915928
Other IDs: Chronic Subdural Hematoma,   Eudra CT nummer 2009-010058-37
First Received Date: June 3, 2009
Start Date: July 2009
Completion Date:
Last Verified Date: July 2010
Acronym: KSDH
Primary Completion Date: June 2011
Outcome Measures: Recurrence of chronic subdural hematoma after surgical removal;   Composition of chronic subdural hematoma fluid
6 Recruiting Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient 

Conditions: Wound Complication;   Obesity
Intervention: Procedure: Removal of surgical skin staples
Sponsor: Greenville Hospital System University Medical Center
Gender: Female
Group: Adult
Phases: Phase II / Phase III
Number Enrolled: 500
Funded By: Other
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID: NCT01114451
Other IDs: Pro00002576
First Received Date: April 16, 2010
Start Date: October 2009
Completion Date: December 2013
Last Verified Date: February 2011
Acronym:
Primary Completion Date: November 2013
Outcome Measures: Number of participants with a superficial wound disruption as a measure of efficacy.;   Number of participants who develop a wound seroma.;   Number of participants who develop a hematoma of the wound.;   Number of participants who develop a surgical site infection;   Frequency of Visual Analogue Pain Score
7 Recruiting Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain 

Conditions: Thyroid Carcinoma;   Thyroidectomy
Intervention: Drug: Usage of Fibrin sealant
Sponsor: Samsung Medical Center
Gender: Both
Age Groups: Adult / Senior
Phase: Phase III
Number Enrolled: 44
Funded By: Other
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID: NCT01126060
Other IDs: 2009-12-093
First Received Date: April 15, 2010
Start Date: February 2010
Completion Date:
Last Verified Date: May 2010
Acronym:
Primary Completion Date: August 2010
Outcome Measures: Postoperative drain amount;   seroma / hematoma
8 Not yet recruiting The Application of Near Infrared Spectroscopy (NIRS) in the Detection of Lower Limb Compartment Syndrome 

Condition: Compartment Syndrome
Intervention: Device: Monitoring of StO2
Sponsor: University of Birmingham NHS Foundation Trust
Gender: Both
Age Groups: Child / Adult / Senior
Phase:
Number Enrolled: 120
Funded By: Other
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
NCT ID: NCT00921271
Other IDs: RRK3786
First Received Date: June 15, 2009
Start Date: September 2009
Completion Date: November 2010
Last Verified Date: June 2009
Acronym:
Primary Completion Date: November 2010
Outcome Measures: Absolute limb StO2 at limb perfusion pressures ≤ 30 mmHg.;   Control corrected limb StO2 at limb perfusion pressures ≤ 30 mmHg.;   Correlation between absolute limb StO2 and limb perfusion pressures.;   Correlation between control corrected limb StO2 and limb perfusion pressures.;   Incidence of compartment syndrome in study population.;   Survival to discharge.
9 Not yet recruiting Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis? 

Condition: Breast Reconstruction
Intervention: Other: Cultures taken from the drain discharge
Sponsor: Sheba Medical Center
Gender: Female
Age Groups: Adult / Senior
Phase:
Number Enrolled: 100
Funded By: Other
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
NCT ID: NCT00973544
Other IDs: SHEBA -08-5530 -EW- CTIL
First Received Date: September 8, 2009
Start Date: September 2009
Completion Date:
Last Verified Date: September 2009
Acronym:
Primary Completion Date:
Outcome Measure:

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