Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Neoplasm Metastasis

Abortion, Spontaneous

Abortion, Habitual

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Neoplastic Processes

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

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Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

gamma-Globulins

Rho(D) Immune Globulin

Immunologic Factors

Repeated infusions of intravenous immunoglobulin in early pregnancy

Intravenous infusions, 25-35 g each time, 4th to 15th gestational week

Intravenous immunoglobulin

Repeated infusions of Human Albumin 5%, 250-350 ml between 4th and 15th gestational week

Human albumin

Ole B. Christiansen, MD, D.M.Sc.

The investigators want to test whether infusions of intravenous immunoglobulin - a blood product known to modify immune responses - in early pregnancy will increase the chance of a subsequent live birth in women with three or more miscarriages after a birth and a total of at least four miscarriages. This will be done in a trial where 82 patients will be randomly allocated to infusions with intravenous immunoglobulin or placebo during pregnancy.

Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage

A Randomized, Placebo-controlled, Double-blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage

The Ministry of Science, Technology and Innovation, Denmark

Rigshospitalet, Denmark

consultant

Digestive System Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Rare Diseases

Pancreatic Neoplasms

Fistula

Gastroparesis

Anastomotic Leak

Pancreatic Fistula

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pathological Conditions, Anatomical

Digestive System Fistula

Postoperative Complications

Stomach Diseases

Paralysis

Neurologic Manifestations

Pancreatic Cancer

Intravenous human albumin 1g/kg at skin incision running at 100ml/hour

Intravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour

Ian Chik

Sarah I Liew

Sarah I Liew, MBBS

Farrah-Hani Imran

Azarinah Izaham

Zamri Zuhdi

Azlanuddin Azman

Razman Jarmin

Fahrol F Jaafar

Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes are broadly categorized to disease-related, patient-related and operative factors. Whereas an inexhaustible list of study exists on looking at reducing PD complication rates with respect to the above-mentioned factors, it was only recently that more attention has been given to the impact of perioperative and intraoperative fluid regimes on PD outcomes. This study takes interest in the impact of intraoperative fluid regimes on PD outcomes. The objective of this investigation is to compare the outcomes with the use of intraoperative intravenous human albumin versus standard intraoperative fluid regimes.

This is a randomized controlled trial being conducted at the Universiti Kebangsaan Malaysia Medical Center (UKMMC) with two arms; the control and treatment arms. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes. Primary endpoint will be overall complication rates whilst secondary endpoints are length of hospitalization, length of ICU care, duration of gastroparesis, pancreatic fistula rates, surgical site infection rates, duration of surgery and intraoperative bleeding.

Beyond the intraoperative fluid regimes, postoperative care follows the standardised UKMMC Enhanced Recovery After Surgery (ERAS) protocols which saw an improvement in overall outcomes in patients who underwent pancreaticoduodenectomies (PD). Preoperative care will include nutrition optimisation, counselling, antimicrobial prophylaxis, perioperative glycemic control and near-zero fluid balance.

Data collection will include:

i. preoperative data: age, sex, ethnicity, BMI on admission, date of admission, comorbidities and the New York Heart Association (NYHA) functional status classification. Further information will include biochemical markers such as serum albumin albumin, white cell count (WCC), renal functions.

ii. Intraoperative information: duration of surgery, estimated blood loss, pancreatic duct size, pancreatic texture, amount and type of fluid administered, fluid balances and type of anastomoses.

iii. postoperative data: fluid balances and renal function of postoperative day 1 to 3, duration of ICU stay, readmission to ICU, length of hospital stay, duration to standard feeds, grading of pancreatic fistula (where relevant), surgical site infection, duration to removal of urinary catheter, cardiac complications, renal and pulmonary complications, deep vein thrombosis, re-operation, and mortality.

This is a randomized controlled trial conducted at the University Kebangsaan Malaysia Medical Center (UKMMC) with two arms; a control a treatment arm. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes.

Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

Complications are defined as any deviation from the normal postoperative course, graded from I to V following the Clavien-Dindo classification of complications whereby Grade I are mild complications not needing any additional interventions and Grade V equates to the most severe complication which is death.

Duration of stay in ICU (in days), where relevant

Rates of postoperative pancreatic fistula

Measured in duration of surgery (in hours \& mins)

Universiti Kebangsaan Malaysia Medical Centre

Stomach Neoplasms

Stomach Cancer

Patients who received intravenous human albumin after gastric cancer surgery

Patients who did not receive intravenous human albumin after gastric cancer surgery

Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.

Birendra K Sah, PH D

Chen Li, PH D

Zhenggang Zhu, PH D

We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

Anastomotic leakage after gastric cancer surgery is not very common but it is a very critical postoperative complication. Anastomotic leakage severely compromises the recovery after surgery. It increases the overall burden of patients and hospital resources. Postoperative mortality is higher in patients with anastomotic leakage.

Human albumin is routinely administered after surgery with a unproven hypothesis that the human albumin is beneficial to prevent anastomotic leakage. We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery

Association of Human Albumin With Anastomotic Leakage After Gastric Cancer Surgery

The rate of anastomotic leakage were compared among both groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage	NCT00722475	Secondary Recur...	Intravenous imm... Human albumin	18 Years - 40 Years	Rigshospitalet, Denmark
Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes	NCT04418739	Pancreaticoduod... Pancreatic Fist... Delayed Gastric... Pancreatic Canc... Anastomotic Lea...	Human albumin	-	Universiti Kebangsaan Malaysia Medical Centre
Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery	NCT04490668	Gastric Cancer Anastomotic Lea...	Human albumin	18 Years - 90 Years	Ruijin Hospital
Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage	NCT00722475	Secondary Recur...	Intravenous imm... Human albumin	18 Years - 40 Years	Rigshospitalet, Denmark
Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes	NCT04418739	Pancreaticoduod... Pancreatic Fist... Delayed Gastric... Pancreatic Canc... Anastomotic Lea...	Human albumin	-	Universiti Kebangsaan Malaysia Medical Centre

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