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Coagulation Defect; BleedingPhase 2NCT02622126

Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia

A Phase 2 study testing hydroxyethyl starch (6% 130/0.4), Hyperbaric bupivacaine and Morphine in people with Coagulation Defect; Bleeding, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Maternal hypotension is the most frequent complication of a spinal Anesthesia. The prevention of spinal hypotension appears more likely to decrease the frequency and severity of associated adverse maternal symptoms than the treatment of established hypotension. Read more about this study

Who is it for?
Ages 19 to 50 years, women only
Conditions the study is for
Coagulation Defect; Bleeding
What is being tested?
hydroxyethyl starch (6% 130/0.4), Hyperbaric bupivacaine and Morphine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
Jan 2016to Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • American Society of Anesthesiologist (ASA) status I or II
  • Aged >18 years
  • Singleton pregnancy
  • Gestational age ≥ 37 weeks
  • Height ≥ 150 cm and ≤ 180 cm
  • Weight > 50 kg and < 100 kg
  • Eligible for spinal anesthesia
  • Elective cesarean delivery

Who cannot join

  • Multiple pregnancies
  • Cardiovascular disease cerebrovascular disease
  • Diabetes Mellitus
  • Hematological problems
  • Abnormal coagulation tests
  • Anticoagulant use
Show all 20Show fewer
  • Hemorrhagic syndromes of pregnancy (placenta previa or accidental hemorrhage)
  • Regular NSAIDS treatment
  • HELLP syndrome
  • Severe preeclampsia
  • Eclampsia
  • Termination of pregnancy for any cause
  • Peripheral neuropathy or chronic pain syndrome
  • Local infection or injury at the needle entry point
  • Known hypersensitivity reaction to local anesthetic, starch allergy
  • Height < 150 cm and > 180 cm
  • Weight < 50 kg and > 100 kg
  • Patient refusing spinal anesthesia
  • Fetal anomalies
  • Fetal distress or cases with umbilical cord prolapsed

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Medicine

    Asyut, Asyut Governorate

Other trials in Egypt

About this study

Official title: The Effects of Colloid Pre-Loading on D-Dimer of the Mother and Her Baby During Cesarean Section Under Spinal Anesthesia for Mild Preeclampsia

Maternal hypotension is the most frequent complication of a spinal Anesthesia. The prevention of spinal hypotension appears more likely to decrease the frequency and severity of associated adverse maternal symptoms than the treatment of established hypotension. Intravenous fluid administration prior to spinal anesthesia for caesarean section is accepted standard practice. The choice of fluid depends on individual and institutional habit, material cost (crystalloid is considerably cheaper) and the perceived relative benefits and risks. Uncommon but potentially serious adverse effect of colloids is impaired coagulation. Although pregnancy is associated with hypercoagulability, little is known about the effects of colloid preloading on coagulation in pregnant patients.

Read the detailed description

The patients were divided into two equal group of thirty patients in each group; Control group (normotensive pregnant women) and Mild preeclampsia group. In both groups patients preloaded with 500 mL hydroxyethyl starch (HES) 6% (130/0.4) (Voluven). Spinal anesthesia will be performed with intrathecal 10-12 mg hyperbaric bupivacaine in addition to 200 meg morphine. The patient was placed supine with left lateral tilt to alleviate aortocaval compression. 10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used co loading during the duration of the operation. Blood pressure was measured and recorded every three minutes. If severe hypotension (fall of > 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used. The blood pressure will rechecked 1 minute after each doses of ephedrine. If hypotension persisted after 30 mg of ephedrine, an additional 2 ml/kg of isotonic 0.9 NaCl solutions will be infused rapidly. Maternal hypotension is defined as at least a single administration of ephedrine within the period from induction of spinal anesthesia until transfer to postoperative recovery unit. Reactive hypertension is characterized as a blood pressure 20% greater than baseline mean levels after the use of the vasopressor. Bradycardia is defined as a fall of >30% of heart rate from baseline or <50 beats /minute. Bradycardia, and when associated with hypotension it will be treated with 0.5 mg of atropine intravenous. Upon completion of the cesarean section, the subject will be transported to the postanesthesia care unit (PACU).

Being tested
hydroxyethyl starch (6% 130/0.4), Hyperbaric bupivacaine, Morphine, Isotonic 0.9 sodium chloride (NaCl) solution, Ephedrine
Keywords
Preloading, Colloid, Cesarean section, D-dimer, Hypotension
Medical subject headings
Hemostatic Disorders, Hemorrhage, Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hydroxyethyl starch (6% 130/0.4)Drug

    Also called Voluven

    preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).

  • Hyperbaric bupivacaineDrug

    Also called Marcaine

    Sub arachnoid 10-12 mg hyperbaric bupivacaine

  • MorphineDrug

    Sub arachnoid 200 meg morphine

  • Isotonic 0.9 sodium chloride (NaCl) solutionDrug

    Also called Normal saline

    10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation

  • EphedrineDrug

    If severe hypotension (fall of > 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.

  • AtropineDrug

    Bradycardia (fall of >30% of heart rate from baseline or <50 beats /minute and when associated with hypotension) will treated with 0.5 mg of atropine intravenous.

Study groups in NCT02622126
Study groupRoleWhat they receive
Normotensive pregnant women groupActive comparatorPreloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6% 130/0.4) (Voluven). Sub arachnoid 10-12 mg hyperbaric bupivacaine Sub arachnoid 200 meg morphine Isotonic 0.9 sodium chloride (NaCl) solution ( 10 ml/kg) will be used as co loading during the duration of the operation Ephedrine 6 me intravenous will be used to treat severe hypotension (fall of > 20% of mean arterial pressure from baseline) Atropine 0.5 mg intravenous will be used to treat bradycardia (fall of >30% of heart rate from baseline or <50 beats /minute and when associated with hypotension)
Receives: Drug: hydroxyethyl starch (6% 130/0.4); Drug: Hyperbaric bupivacaine; Drug: Morphine; Drug: Isotonic 0.9 sodium chloride (NaCl) solution; Drug: Ephedrine; Drug: Atropine
Mild preeclampsia pregnant women groupActive comparatorPreloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6% 130/0.4) (Voluven). Sub arachnoid 10-12 mg hyperbaric bupivacaine Sub arachnoid 200 meg morphine Isotonic 0.9 sodium chloride (NaCl) solution (NaCl) solution ( 10 ml/kg) will be used as co loading during the duration of the operation Ephedrine 6 me intravenous will be used to treat severe hypotension (fall of > 20% of mean arterial pressure from baseline) Atropine 0.5 mg intravenous will be used to treat bradycardia (fall of >30% of heart rate from baseline or <50 beats /minute and when associated with hypotension)
Receives: Drug: hydroxyethyl starch (6% 130/0.4); Drug: Hyperbaric bupivacaine; Drug: Morphine; Drug: Isotonic 0.9 sodium chloride (NaCl) solution; Drug: Ephedrine; Drug: Atropine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coagulation defect (detection of D-Dimer) of the mother

    Blood samples for detection of D-Dimer were taken from the mother preoperatively (before colloid administration) and another one at the end of the operation

    Measured: Pre and post cesarean delivery, an expected average of 90 minutes

  2. Coagulation defect (detection of D-Dimer) of the baby

    Blood sample for detection of D-Dimer was taken from the umbilical cord of the fetus before clamping

    Measured: Pre and post cesarean delivery, an expected average of 90 minutes

Secondary outcomes (5)

  1. Maternal hypotension (fall of > 20% of MAP (mm Hg ) from baseline)

    fall of > 20% of MAP (mm Hg ) from baseline

    Measured: Post spinal for cesarean delivery, an expected average of 4 hours

  2. Ephedrine treatment (Ephedrine total dosage (mg))

    Ephedrine total dosage (mg)

    Measured: Post spinal for cesarean delivery, an expected average of 4 hours

  3. Atropine treatment (atropine total dosage (mg))

    atropine total dosage (mg)

    Measured: Post spinal for cesarean delivery, an expected average of 4 hours

  4. Hemoglobin concentration

    Blood samples for detection of hemoglobin concentration gm/dL

    Measured: Pre and post cesarean delivery, an expected average of 4 hours

  5. Platelet count

    Blood samples for detection of platelet count (109/L )

    Measured: Pre and post cesarean delivery, an expected average of 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02622126
Sponsor's protocol ID
IRB0000871175
Status last verified
Nov 2016
First submitted
1 Dec 2015
Last updated
8 Nov 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing hydroxyethyl starch (6% 130/0.4), Hyperbaric bupivacaine and Morphine in people with Coagulation Defect; Bleeding, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coagulation defect (detection of D-Dimer) of the mother (time frame: Pre and post cesarean delivery, an expected average of 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02622126.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.

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